An observational study in Pediatric Disorder, Pediatric Obesity and Primary Hypertension, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Wake Forest University Health Sciences · Observational
Pediatric primary hypertension is increasingly common, occurring in 5-10% of normal-weight children and up to 25% of children with obesity. It is a risk factor for adult cardiovascular and renal disease. But even during childhood, hypertension is associated with significant morbidity, including cognitive impairment and organ damage. In the heart and kidneys, this organ damage is characterized by thickened heart muscle (left ventricular hypertrophy) and spillage of protein in the urine (albuminuria). Obese children are also at risk for fatty liver disease. However, the cause of pediatric primary hypertension, the role of obesity, and the mechanisms behind heart and kidney injury are poorly understood. Due to these limitations, there are no first-line medications, and treatment is often inadequate. An altered renin-angiotensin system may cause primary hypertension and related organ damage. Evidence suggests uric acid, FGF23, klotho, and obesity play a role in renin-angiotensin system-mediated injury. An improved comprehension of the pathophysiology of pediatric primary hypertension could enhance clinical care by targeting treatment to the cause of disease and informing novel measurement of organ damage.
This proposal is to begin to elucidate the origins of pediatric primary hypertension and determine how it causes cardiac and renal disease. The primary hypothesis is than an altered renin-angiotensin system leads to the development of pediatric primary hypertension-related organ damage in the heart and kidney, specifically left ventricular hypertrophy and albuminuria. It is postulated that relative increase in angiotensin (Ang) ll tone compared to Ang-(1-7) tone in the circulation and the kidney (measured in the plasma and urine, respectively) leads to disease. The secondary hypotheses are that abnormalities in renin-angiotensin system tone are related to higher uric acid and FGF23, lower klotho, and, with concurrent obesity, contribute to nonalcoholic fatty liver disease. The investigators will recruit 100 subjects aged 5-17 years who are referred for a new diagnosis of pediatric primary hypertension to the Pediatric Nephrology clinic at Brenner Children's Hospital, 50 normotensive subjects with obesity recruited from the Brenner Families-in-Training program, and 10 healthy normotensive from a general pediatrics clinic in the Wake Forest Baptist Health System.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 35 is below the median of 180 across 235 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients of the Pediatric Nephrology Clinic and Pediatric Gastroenterology Clinic at Brenner Children's Hospital. Patients from a general pediatric clinic at Wake Forest Baptist Health.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinical data will be collected from the electronic medical record, including height, weight, age, sex, parent-reported race, and past medical and family histories. Antihypertensive medication type and dosage will be recorded. Blood and urine samples will be collected at baseline and yearly for three years. All subjects will receive baseline and yearly echocardiograms. Subjects with overweight/obesity (BMI \>=85th percentile for age and sex) will receive baseline and yearly ultrasounds of the liver to evaluate for hepatic fat infiltration. Auscultated, continuous and ambulatory blood pressure will be measured at baseline and yearly.
Clinical data will be collected from the electronic medical record, including height, weight, age, sex, parent-reported race, and past medical and family histories. Subjects will receive a baseline ultrasound of the liver to evaluate hepatic fat infiltration as per standard of care. Blood and urine will be collected at baseline to measure liver function (AST, ALT) and uric acid, angiotensin ll, and angiotensin-(1-7).
Clinical data will be collected from the electronic medical record, including height, weight, age, sex, parent-reported race, and past medical and family histories. Subjects will have baseline echocardiograms. Blood pressure will be measured at baseline and at one year. Continuous blood pressure and ambulatory blood pressure monitoring will be assessed at baseline. Blood and urine samples will be used to measure uric acid, FGF23, klotho, and albumin, as well as the predictors angiotensin ll and angiotensin-(1-7).
Left ventricular hypertrophy
Left ventricular hypertrophy according to elevated left ventricular mass index (\>51 g/m\^2.7 (\>8 years of age, both sexes) or \>115 g/body surface area (males) and \>95 g/body surface area (females)) on serial echocardiogram.
Time frame: Yearly for 3 years
Albuminuria
Albumin-to-creatinine ratio \>30 mg/g
Time frame: Yearly for 3 years
Ambulatory systolic blood pressure load
Percent of 24-hour ambulatory systolic blood pressure above the 95th percentile (\>25% abnormal)
Time frame: Yearly for 3 years
Ambulatory diastolic blood pressure load
Percent of 24-hour ambulatory diastolic blood pressure above the 95th percentile (\>25% abnormal)
Time frame: Yearly for 3 years
Ambulatory systolic blood pressure nocturnal dipping
Percent of 24-hour ambulatory systolic blood pressure that drops below the mean blood pressure overnight
Time frame: Yearly for 3 years
Ambulatory diastolic blood pressure nocturnal dipping
Percent of 24-hour ambulatory diastolic blood pressure that drops below the mean blood pressure overnight
Time frame: Yearly for 3 years
Clinic systolic blood pressure
Auscultated systolic blood pressure (mmHg)
Time frame: Yearly for 3 years
Clinic diastolic blood pressure
Auscultated diastolic blood pressure (mmHg)
Time frame: Yearly for 3 years
Nonalcoholic fatty liver disease
Fat infiltration (yes or no) as measured on liver ultrasound with elastography in subjects with overweight/obesity (BMI \>=85th percentile)
Time frame: Yearly for 3 years
Continuous systolic blood pressure
Systolic blood pressure measured continuously for 10 minutes (mmHg)
Time frame: Yearly for 3 years
Continuous diastolic blood pressure
Diastolic blood pressure measured continuously for 10 minutes (mmHg)
Time frame: Yearly for 3 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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