An observational study in Hypertension, Left Ventricular Hypertrophy and Left Ventricular Dysfunction, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 7 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Wake Forest University Health Sciences · Observational
Studying the causal roles of components of the renin-angiotensin-aldosterone system (including angiotensin-(1-7) (Ang-(1-7)), angiotensin-converting enzyme 2 (ACE2), Ang II, and ACE), uric acid, and klotho in pediatric hypertension and related target organ injury, including in the heart, kidneys, vasculature, and brain. Recruiting children with a new hypertension diagnosis over a 2-year period from the Hypertension and Pediatric Nephrology Clinics affiliated with Brenner Children's Hospital at Atrium Health Wake Forest Baptist and Atrium Health Levine Children's Hospital. Healthy control participants will be recruited from local general primary care practices. Collecting blood and urine samples to analyze components of the renin-angiotensin-aldosterone system (Ang-(1-7), ACE2, Ang II, ACE), uric acid, and klotho, and measuring blood pressure, heart structure and function, autonomic function, vascular function, and kidney function at baseline, year 1, and year 2. Objectives are to investigate phenotypic and treatment response variability and to causally infer if Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho contribute to target organ injury due to hypertension.
This longitudinal prospective cohort study is recruiting children and adolescents aged 7-18 years with newly diagnosed primary hypertension over a 2-year period from the Hypertension and Pediatric Nephrology Clinics affiliated with Brenner Children's Hospital at Atrium Health Wake Forest Baptist, which sees over 300 new patients a year, and the Pediatric Nephrology Clinic at Atrium Health Levine Children's Hospital (Hypertension Cohort). Also recruiting healthy control participants aged 7-18 years with normal blood pressure from local primary care practices (Control Cohort). Collecting blood and urine to analyze Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho and measuring pediatric-specific outcomes (blood pressure (casual and ambulatory monitoring), indices of heart structure and function on echocardiogram (left ventricular systolic and diastolic function, left ventricular hypertrophy, etc.), kidney function (creatinine, estimated glomerular filtration rate, albuminuria, proteinuria, urine sodium/potassium), autonomic function (heart rate variability, blood pressure variability, baroreflex sensitivity), and vascular function (arterial stiffness, augmentation index)) at baseline and year 1 (Hypertension Cohort and Control Cohort) and year 2 (Hypertension Cohort). The objectives are to investigate if Ang-(1-7), ACE2, Ang II, and ACE identify phenotypic and treatment response variability and to causally infer if Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho contribute to target organ injury, with these Specific Aims:
Aim 1:
(1) Determine if plasma Ang-(1-7) or urine Ang-(1-7)/creatinine differ between the Hypertension vs. Control Cohorts and (2) assess if plasma Ang-(1-7) or urine Ang-(1-7)/creatinine mediate the effect of lisinopril-induced blood pressure reduction on the outcomes (change in heart function and structure, autonomic function, vascular function, and kidney function).
Hypothesis 1a: Baseline Ang-(1-7) is lower in the Hypertension vs. Control Cohort.
Hypothesis 1b: Increased Ang-(1-7) levels over time mediate the effect of lisinopril-induced decreased blood pressure on improved outcomes over 2 years in the Hypertension Cohort.
Aim 2:
(1) Evaluate if plasma Ang-(1-7) or urine Ang-(1-7)/creatinine predict treatment response in participants in the Hypertension Cohort (change in casual blood pressure, ambulatory blood pressure, heart function/structure, autonomic function, vascular function, and kidney function); (2) compare to plasma renin activity and aldosterone; and (3) employ sensitivity analyses to quantify the impact of unmeasured confounding.
Hypothesis 2: Lower baseline Ang-(1-7) predicts greater outcome improvements in the Hypertension Cohort with lower unmeasured confounding and with greater predictive ability compared to plasma renin activity and aldosterone.
Aim 3:
Determine if plasma Ang-(1-7) or urine Ang-(1-7)/creatinine mediate the effects of uric acid and klotho on the outcomes in participants in the Hypertension Cohort. (1) Apply causal mediation to estimate if plasma Ang-(1-7) mediates the effects of uric acid on the outcomes (change in casual blood pressure, ambulatory blood pressure, heart function/structure, autonomic function, and vascular function). (2) Apply causal mediation to estimate if urine Ang-(1-7)/creatinine mediates the effects of klotho on the outcomes (change in casual blood pressure, ambulatory blood pressure, and kidney function).
Hypothesis 3a: Lower plasma Ang-(1-7) mediates the effect of high uric acid on the outcomes in the Hypertension Cohort.
Hypothesis 3b: Lower urine Ang-(1-7)/creatinine mediates the effect of low klotho on the outcomes in the Hypertension Cohort.
Anticipated results have great potential to impact patient care by establishing Ang-(1-7), ACE2, Ang II, and ACE as biomarkers of treatment response, by establishing how Ang-(1-7) and other components of the renin-angiotensin-aldosterone system change in response to an ACE inhibitor, by indicating which patients would benefit most from ACE inhibitors, by identifying novel etiologies of hypertension centered on alterations to the renin-angiotensin-aldosterone system, uric acid, and klotho, and by leading to novel treatments. Indeed, these have been questions of great interest during the COVID-19 pandemic, as ACE2 is the binding site for Severe acute respiratory syndrome (SARS)-CoV-2. Ultimately, the results from this study will improve patient outcomes by promoting cardiovascular health and preventing cardiovascular disease across the lifecourse.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 125 is below the median of 350 across 1,163 observational studies indexed under Hypertension.
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Hypertension Cohort: Participants will be recruited from among new patients referred to the Hypertension Clinic at Brenner Children's Hospital. Patient population at this clinic, which sees over 300 new patients/year, is 55% White, 25% Black, 16% Hispanic, and 62% male. Goal is to enroll 100 participants over a 2-year period.
Control Cohort: Participants for this cohort will be recruited from among healthy patients seen at local pediatrics practices. Goal is to enroll 25 participants over a 2-year period, frequency-matched to the Hypertension Cohort on age, self-identified race, and sex.
INCLUSION CRITERIA: HYPERTENSION COHORT
Confirmed new diagnosis of primary hypertension: no identifiable secondary cause, referred to hypertension or nephrology clinic
EXCLUSION CRITERIA: HYPERTENSION COHORT
BP confirmed as normal or in the elevated BP category based on ≥3 prior office BP measurements on separate days;
INCLUSION CRITERIA: CONTROL COHORT
Normal BP based on ≥3 prior office BP measurements on separate days;
EXCLUSION CRITERIA: CONTROL COHORT
Elevated BP or hypertension, based on ≥3 prior office BP measurements on separate days:
Participants with newly diagnosed primary hypertension
Healthy participants with normal blood pressure
Baseline Urine Angiotensin-(1-7)/Creatinine Ratio
Urine angiotensin-(1-7) quantified by a highly developed radioimmunoassay well validated against mass spectrometry and standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Angiotensin-(1-7)/Creatinine Ratio
Urine angiotensin-(1-7) quantified by a highly developed radioimmunoassay well validated against mass spectrometry and standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Angiotensin II/Angiotensin-(1-7) Ratio
Urine angiotensin II and angiotensin-(1-7) quantified by highly developed radioimmunoassays well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Angiotensin II/Angiotensin-(1-7) Ratio
Urine angiotensin II and angiotensin-(1-7) quantified by highly developed radioimmunoassays well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Plasma Angiotensin-(1-7) Level
Plasma angiotensin-(1-7) quantified by a highly developed radioimmunoassay well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Plasma Angiotensin-(1-7) Level
Plasma angiotensin-(1-7) quantified by a highly developed radioimmunoassay well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Plasma Angiotensin II/Angiotensin-(1-7) Ratio
Plasma angiotensin II and angiotensin-(1-7) quantified by highly developed radioimmunoassays well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Plasma Angiotensin II/Angiotensin-(1-7) Ratio
Plasma angiotensin II and angiotensin-(1-7) quantified by highly developed radioimmunoassays well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Serum Uric Acid Level
Serum uric acid quantified by a validated uricase assay. Report as a continuous variable with measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline
Change in Serum Uric Acid Level
Serum uric acid quantified by a validated uricase assay. Report as a continuous variable with measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Plasma Klotho Level
Plasma α-klotho quantified by a well-validated ELISA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Plasma Klotho Level
Plasma α-klotho quantified by a well-validated ELISA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Klotho/Creatinine Ratio
Urine α-klotho quantified by a well-validated ELISA and standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Klotho/Creatinine Ratio
Urine α-klotho quantified by a well-validated ELISA and standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Manual Systolic Blood Pressure
Average of 3 manual measurements per national guidelines. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline
Change in Manual Systolic Blood Pressure
Average of 3 manual measurements per national guidelines. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Manual Diastolic Blood Pressure
Average of 3 manual measurements per national guidelines. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline
Change in Manual Diastolic Blood Pressure
Average of 3 manual measurements per national guidelines. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Manual Systolic Blood Pressure Z-score
Average of 3 manual measurements per national guidelines with calculated z-score referenced to normative values by age, sex, and height. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline
Change in Manual Systolic Blood Pressure Z-score
Average of 3 manual measurements per national guidelines with calculated z-score referenced to normative values by age, sex, and height. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Manual Diastolic Blood Pressure Z-score
Average of 3 manual measurements per national guidelines with calculated z-score referenced to normative values by age, sex, and height. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline
Change in Manual Diastolic Blood Pressure Z-score
Average of 3 manual measurements per national guidelines with calculated z-score referenced to normative values by age, sex, and height. Report measures of central tendency (e.g., mean) and dispersion (e.g., standard deviation, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure 24-Hour Mean
Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP over a 24-hour period. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure 24-Hour Mean
Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP over a 24-hour period. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure 24-Hour Mean
Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP over a 24-hour period. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure 24-Hour Mean
Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP over a 24-hour period. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Left Ventricular Mass Height Index
Left ventricular mass measured via echocardiogram and indexed to height as g/m\^2.7. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Left Ventricular Mass Height Index
Left ventricular mass measured via echocardiogram and indexed to height as g/m\^2.7. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Left Ventricular Mass Body Surface Area Index
Left ventricular mass measured via echocardiogram and indexed to body surface area (BSA) as g/BSA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Left Ventricular Mass Body Surface Area Index
Left ventricular mass measured via echocardiogram and indexed to body surface area (BSA) as g/BSA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Left Ventricular Hypertrophy
Measured via echocardiogram. Binary variable defined as left ventricular mass index (LVMI) \>51 g/m\^2.7 (all participants), \>115 g/body surface area (BSA) (males), or \>95 g/BSA (females), per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Left Ventricular Hypertrophy
Measured via echocardiogram. Binary variable defined as left ventricular mass index (LVMI) \>51 g/m\^2.7 (all participants), \>115 g/body surface area (BSA) (males), or \>95 g/BSA (females), per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Albumin/Creatinine Ratio
Measured in fasting first-morning urine samples. Albumin analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Albumin/Creatinine Ratio
Measured in fasting first-morning urine samples. Albumin analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Albuminuria
Measured in fasting first-morning urine samples. Albumin analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as an albumin/creatinine ratio \>30 mg/g. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Albuminuria
Measured in fasting first-morning urine samples. Albumin analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as an albumin/creatinine ratio \>30 mg/g. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Serum Creatinine Level
Measured in the serum and analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Serum Creatinine Level
Measured in the serum and analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Estimated Glomerular Filtration Rate
Estimated using validated, non-race-based, age-appropriate equations (modified Schwartz equation and height- and age-based full-age-spectrum equations with serum creatinine (analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry) and serum cystatin C (analyzed via the Clinical Laboratory). Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Estimated Glomerular Filtration Rate
Estimated using validated, non-race-based, age-appropriate equations (modified Schwartz equation and height- and age-based full-age-spectrum equations with serum creatinine (analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry) and serum cystatin C (analyzed via the Clinical Laboratory). Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Sodium Concentration
Measured sodium and creatinine in fasting, first-morning urine samples. Sodium analyzed in the Clinical Laboratory, and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Sodium Concentration
Measured sodium and creatinine in fasting, first-morning urine samples. Sodium analyzed in the Clinical Laboratory, and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Sodium/Potassium Ratio
Measured sodium and potassium in fasting, first-morning urine samples and analyzed in the Clinical Laboratory. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Sodium/Potassium Ratio
Measured sodium and potassium in fasting, first-morning urine samples and analyzed in the Clinical Laboratory. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Plasma Renin Activity
Measured in the plasma with a well-validated assay. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Plasma Renin Activity
Measured in the plasma with a well-validated assay. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Serum Aldosterone Level
Measured in the serum with a well-validated assay. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Serum Aldosterone Level
Measured in the serum with a well-validated assay. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Angiotensin II/Creatinine Ratio
Urine angiotensin II quantified by a highly developed radioimmunoassay well validated against mass spectrometry and standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Angiotensin II/Creatinine Ratio
Urine angiotensin II quantified by a highly developed radioimmunoassay well validated against mass spectrometry and standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Angiotensin-Converting Enzyme 2 Level
Measure angiotensin-converting enzyme 2 content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. Standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Angiotensin-Converting Enzyme 2 Level
Measure angiotensin-converting enzyme 2 content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. Standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Angiotensin-Converting Enzyme Level
Measure angiotensin-converting enzyme content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. Standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Angiotensin-Converting Enzyme Level
Measure angiotensin-converting enzyme content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. Standardized to urine creatinine, quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Angiotensin-Converting Enzyme/Angiotensin-Converting Enzyme 2 Ratio
Measure angiotensin-converting enzyme and angiotensin-converting enzyme 2 content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Angiotensin-Converting Enzyme/Angiotensin-Converting Enzyme 2 Ratio
Measure angiotensin-converting enzyme and angiotensin-converting enzyme 2 content and enzymatic activity in first-morning urine samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Plasma Angiotensin II Level
Plasma angiotensin II quantified by a highly developed radioimmunoassay well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Plasma Angiotensin II Level
Plasma angiotensin II quantified by a highly developed radioimmunoassay well validated against mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Serum Angiotensin-Converting Enzyme 2 Level
Measure angiotensin-converting enzyme 2 content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Serum Angiotensin-Converting Enzyme 2 Level
Measure angiotensin-converting enzyme 2 content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Serum Angiotensin-Converting Enzyme Level
Measure angiotensin-converting enzyme content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Serum Angiotensin-Converting Enzyme Level
Measure angiotensin-converting enzyme content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Serum Angiotensin-Converting Enzyme/Angiotensin-Converting Enzyme 2 Ratio
Measure angiotensin-converting enzyme and angiotensin-converting enzyme 2 content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Serum Angiotensin-Converting Enzyme/Angiotensin-Converting Enzyme 2 Ratio
Measure angiotensin-converting enzyme and angiotensin-converting enzyme 2 content and enzymatic activity in serum samples using established fluorescence-based methods. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Hyperuricemia
Serum uric acid quantified by a validated uricase assay. Hyperuricemia defined as ≥8.0 mg/dl, reported with relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Hyperuricemia
Serum uric acid quantified by a validated uricase assay. Hyperuricemia defined as ≥8.0 mg/dl, reported with relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Manual Blood Pressure Classification
Based on average of 3 manual blood pressure (BP) measurements per age-specific national guidelines and age, sex, and height-based BP percentile. Categorized as a 4-level ordinal variable: (1) normal, \<90th percentile or \<120/80 mmHg; (2) elevated BP, ≥90th to \<95th percentile or 120-129/\<80 mmHg; (3) stage 1 hypertension, ≥95th to \<95th percentile + 12 mmHg or 130-139/80-89 mmHg; (4) stage 2 hypertension, ≥95th percentile + 12 mmHg or ≥140/90 mmHg). Report relative measures (e.g., odds ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Manual Blood Pressure Classification
Based on average of 3 manual blood pressure (BP) measurements per age-specific national guidelines and age, sex, and height-based BP percentile. Categorized as a 4-level ordinal variable: (1) normal, \<90th percentile or \<120/80 mmHg; (2) elevated BP, ≥90th to \<95th percentile or 120-129/\<80 mmHg; (3) stage 1 hypertension, ≥95th to \<95th percentile + 12 mmHg or 130-139/80-89 mmHg; (4) stage 2 hypertension, ≥95th percentile + 12 mmHg or ≥140/90 mmHg). Report relative measures (e.g., odds ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure 24-Hour Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings over a 24-hour period that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure 24-Hour Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings over a 24-hour period that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure 24-Hour Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings over a 24-hour period that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure 24-Hour Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings over a 24-hour period that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure 24-Hour Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP over 24-hour period divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure 24-Hour Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP over 24-hour period divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure 24-Hour Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP over 24-hour period divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure 24-Hour Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP over 24-hour period divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure Awake Mean
Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP while awake. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure Awake Mean
Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP while awake. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure Awake Mean
Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP while awake. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure Awake Mean
Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP while awake. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure Awake Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings while awake that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure Awake Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings while awake that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure Awake Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings while awake that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure Awake Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings while awake that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure Awake Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while awake divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure Awake Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while awake divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure Awake Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while awake divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure Awake Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while awake divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure Asleep Mean
Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP while asleep. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure Asleep Mean
Measured via ambulatory blood pressure (BP) monitoring. Average systolic BP while asleep. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure Asleep Mean
Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP while asleep. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure Asleep Mean
Measured via ambulatory blood pressure (BP) monitoring. Average diastolic BP while asleep. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure Asleep Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings while asleep that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure Asleep Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of systolic BP readings while asleep that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure Asleep Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings while asleep that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure Asleep Load
Measured via ambulatory blood pressure (BP) monitoring. Proportion of diastolic BP readings while asleep that are ≥95th percentile for height per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure Asleep Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while asleep divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure Asleep Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while asleep divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure Asleep Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while asleep divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure Asleep Index
Measured via ambulatory blood pressure (BP) monitoring. Defined as mean BP while asleep divided by the 95th percentile for sex and height, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Systolic Blood Pressure Nocturnal Dipping
Measured via ambulatory blood pressure (BP) monitoring. Proportion calculated as (\[ mean awake - mean asleep systolic BP \] / \[mean awake systolic BP \]) x 100, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Systolic Blood Pressure Nocturnal Dipping
Measured via ambulatory blood pressure (BP) monitoring. Proportion calculated as (\[ mean awake - mean asleep systolic BP \] / \[mean awake systolic BP \]) x 100, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Diastolic Blood Pressure Nocturnal Dipping
Measured via ambulatory blood pressure (BP) monitoring. Proportion calculated as (\[ mean awake - mean asleep diastolic BP \] / \[mean awake diastolic BP \]) x 100, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Diastolic Blood Pressure Nocturnal Dipping
Measured via ambulatory blood pressure (BP) monitoring. Proportion calculated as (\[ mean awake - mean asleep diastolic BP \] / \[mean awake diastolic BP \]) x 100, per national guidelines. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Inadequate Nocturnal Dipping
Measured via ambulatory blood pressure (BP) monitoring. Binary variable defined as the proportion of BP nocturnal dipping \<10 percent, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Inadequate Nocturnal Dipping
Measured via ambulatory blo od pressure (BP) monitoring. Binary variable defined as the proportion of BP nocturnal dipping \<10 percent, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Ambulatory Hypertension
Measured via ambulatory blood pressure (BP) monitoring. Binary variable defined as mean BP ≥95 percentile for height AND load ≥25 percent for any time period, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Ambulatory Hypertension
Measured via ambulatory blood pressure (BP) monitoring. Binary variable defined as mean BP ≥95 percentile for height AND load ≥25 percent for any time period, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Relative Left Ventricular Wall Thickness
Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Relative Left Ventricular Wall Thickness
Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Elevated Relative Left Ventricular Wall Thickness
Measured via echocardiogram. Binary variable defined as \>0.42, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Elevated Relative Left Ventricular Wall Thickness
Measured via echocardiogram. Binary variable defined as \>0.42, per national guidelines. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Left Ventricular Geometry Classification
Measured via echocardiogram. 4-level ordinal variable defined as (1) normal (normal left ventricular mass index (LVMI) and normal relative left ventricular wall thickness (RLVWT)); 2) concentric remodeling (normal LVMI and high RLVWT); 3) eccentric hypertrophy (high LVMI and normal RLVWT); 4) concentric hypertrophy (high LVMI and high RLVWT), per national guidelines. Report relative measures (e.g., risk ratio, odds ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Left Ventricular Geometry Classification
Measured via echocardiogram. 4-level ordinal variable defined as (1) normal (normal left ventricular mass index (LVMI) and normal relative left ventricular wall thickness (RLVWT)); 2) concentric remodeling (normal LVMI and high RLVWT); 3) eccentric hypertrophy (high LVMI and normal RLVWT); 4) concentric hypertrophy (high LVMI and high RLVWT), per national guidelines. Report relative measures (e.g., risk ratio, odds ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Left Ventricular Systolic Function
Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Left Ventricular Systolic Function
Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Left Ventricular Diastolic Function
Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Left Ventricular Diastolic Function
Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Left Atrial Size
Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Left Atrial Size
Measured via echocardiogram. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Left Atrial Enlargement
Measured via echocardiogram. Binary variable defined ≥29 ml/m\^2, per national guidelines. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Left Atrial Enlargement
Measured via echocardiogram. Binary variable defined ≥29 ml/m\^2, per national guidelines. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Protein/Creatinine Ratio
Measured in fasting first-morning urine samples. Protein analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Urine Protein/Creatinine Ratio
Measured in fasting first-morning urine samples. Protein analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Proteinuria
Measured in fasting first-morning urine samples. Protein analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as a protein/creatinine ratio \>0.2 mg/mg. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Proteinuria
Measured in fasting first-morning urine samples. Protein analyzed in the Clinical Laboratory and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as a protein/creatinine ratio \>0.2 mg/mg. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Serum Cystatin C Level
Measured in the serum and analyzed via the Clinical Laboratory. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline
Change in Serum Cystatin C Level
Measured in the serum and analyzed via the Clinical Laboratory. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Elevated Urine Sodium Concentration
Measured sodium and creatinine in fasting, first-morning urine samples. Sodium analyzed in the Clinical Laboratory, and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as urine sodium/creatinine ratio \>1 mmol/mg. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Elevated Urine Sodium Concentration
Measured sodium and creatinine in fasting, first-morning urine samples. Sodium analyzed in the Clinical Laboratory, and creatinine analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry. Binary variable defined as urine sodium/creatinine ratio \>1 mmol/mg. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Baseline Elevated Urine Sodium/Potassium Ratio
Measured sodium and potassium in fasting, first-morning urine samples and analyzed in the Clinical Laboratory. Binary variable defined as urine sodium/potassium ratio \>1 mmol/mmol. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline
Change in Elevated Urine Sodium/Potassium Ratio
Measured sodium and potassium in fasting, first-morning urine samples and analyzed in the Clinical Laboratory. Binary variable defined as urine sodium/potassium ratio \>1 mmol/mmol. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Baseline through 2 years
Low Estimated Glomerular Filtration Rate
Estimated using validated, non-race-based, age-appropriate equations (modified Schwartz equation and height- and age-based full-age-spectrum equations with serum creatinine (analyzed via a modified Jaffe assay traceable to isotope dilution mass spectrometry) and serum cystatin C (analyzed via the Clinical Laboratory). Defined as \<90 ml/min/1.73 m\^2. Report relative measures (e.g., risk ratio) and measures of dispersion (e.g., 95 percent confidence interval).
Time frame: Through study completion up to 2 years
Baseline Urine Uric Acid/Creatinine Ratio
Measured in fasting first-morning urine samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline
Change in Urine Uric Acid/Creatinine Ratio
Measured in fasting first-morning urine samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Uric Acid Per Glomerular Filtration Rate
Measured in fasting first-morning urine and serum samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Calculated as \[urine uric acid x serum creatinine\] / \[urine creatinine\]. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline
Change in Urine Uric Acid Per Glomerular Filtration Rate
Measured in fasting first-morning urine and serum samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Calculated as \[urine uric acid x serum creatinine\] / \[urine creatinine\]. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline through 2 years
Baseline Fractional Excretion of Urine Uric Acid
Measured in fasting first-morning urine and serum samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Calculated as \[urine uric acid x serum creatinine\] / \[urine creatinine x serum uric acid\]. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline
Change in Fractional Excretion of Urine Uric Acid
Measured in fasting first-morning urine and serum samples. Uric acid quantified by well-validated uricase assay and creatinine via modified Jaffe assay traceable to isotope dilution mass spectrometry. Calculated as \[urine uric acid x serum creatinine\] / \[urine creatinine x serum uric acid\]. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline through 2 years
Baseline Serum Fibroblast Growth Factor 23 Level
Quantified in serum using a validated ELISA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline
Change in Serum Fibroblast Growth Factor 23 Level
Quantified in serum using a validated ELISA. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline through 2 years
Baseline Urine Fibroblast Growth Factor 23 Level
Quantified in first-morning urine using a validated ELISA, standardized to urine creatinine quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline
Change in Urine Fibroblast Growth Factor 23 Level
Quantified in first-morning urine using a validated ELISA, standardized to urine creatinine quantified by a modified Jaffe assay traceable to isotope dilution mass spectrometry. Report measures of central tendency (e.g., mean, median) and dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval).
Time frame: Baseline through 2 years
Baseline Obesity
Height and weight measured in triplicate and average value recorded. Body mass index calculated and obesity defined per national guidelines as body mass index ≥95th percentile for age and sex or ≥30.0 kg/m\^2. Report relative measures (e.g., risk ratio, odds ratio) with measures of dispersion (e.g., 95 percentile confidence interval).
Time frame: Baseline
Baseline Dietary Sodium Intake
Estimated dietary sodium intake from self-administered food frequency questionnaire. Report measures of central tendency (e.g., mean, median) with dispersion (e.g., standard deviation, interquartile range, 95 percentile confidence interval)
Time frame: Baseline
Baseline Disordered Eating
5-item SCOFF questionnaire. Positive if participant answers yes to 2 or more of the 5 questions. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).
Time frame: Baseline
Change in Disordered Eating
5-item SCOFF questionnaire. Positive if participant answers yes to 2 or more of the 5 questions. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).
Time frame: Baseline through 2 years
Baseline Financial Stress
Assessed with a validated questionnaire consisting of one question measured on a 5-point ordinal scale: 1) not hard at all; 2) not very hard; 3) somewhat hard; 4) hard; 5) very hard. Positive if participant reports somewhat hard, hard, or very hard. Report relative measures (e.g., risk ratio, odds ratio) with measures of dispersion (e.g., 95 percentile confidence interval).
Time frame: Baseline
Change in Financial Stress
Assessed with a validated questionnaire consisting of one question measured on a 5-point ordinal scale: 1) not hard at all; 2) not very hard; 3) somewhat hard; 4) hard; 5) very hard. Positive if participant reports somewhat hard, hard, or very hard. Report relative measures (e.g., risk ratio, odds ratio) with measures of dispersion (e.g., 95 percentile confidence interval).
Time frame: Baseline through 2 years
Baseline Food Insecurity
Assessed with a validated questionnaire consisting of two questions both scored on a 3-point ordinal scale: 1) never true; 2) sometimes true; 3) often true. Positive if participant reports somewhat true or often true to either question. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).
Time frame: Baseline
Change in Food Insecurity
Assessed with a validated questionnaire consisting of two questions both scored on a 3-point ordinal scale: 1) never true; 2) sometimes true; 3) often true. Positive if participant reports somewhat true or often true to either question. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).
Time frame: Baseline through 2 years
Baseline Transportation Stress
Assessed with a validated questionnaire consisting of two binary questions. Positive if participant reports yes to either question. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).
Time frame: Baseline
Change in Transportation Stress
Assessed with a validated questionnaire consisting of two binary questions. Positive if participant reports yes to either question. Report relative measures (e.g., risk ratio) with measures of dispersion (e.g., 95 percentile confidence interval).
Time frame: Baseline through 2 years
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification, will be shared with other researchers.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 12 months and ending six years following article publication.
Access criteria: Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose and who provide a methodologically sound proposal. Data will be shared for meta-analysis of individual participant data and/or to achieve aims in the approved proposal.
Started May 2021 (actual). Primary completion is estimated for Dec 2026, 67 months after the start.
Of 345 non-industry observational studies under Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 111. This study's planned 67 months is above that.
Counting every sponsor, half of 426 studies reached it within 38 months; a quarter within 17 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
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