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TerminatedNCT03305562PHREGUpdated Jun 12, 2023

Pediatric Hypertension Registry (PHREG)

An observational study in Hypertension and Pediatric Disorder, sponsored by Wake Forest University Health Sciences. Terminated at 2 sites in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2023-06-12.

Sponsored by Wake Forest University Health Sciences · Observational

Why this study was terminated
Study was a pilot study and the investigators received funding to initiate the main study
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
179
Ages
Up to 17 Years
Sex
All
01

Study summary

Pediatric hypertension is increasingly common and is a precursor for adult cardiovascular and renal disease. But even during childhood, hypertension is associated with significant morbidity, including cognitive impairment and organ damage. However, the cause of pediatric hypertension, the response to treatment, and the mechanisms behind organ damage are incompletely understood. Due to these limitations, there are no first-line medications, and treatment is often inadequate. An improved comprehension of the course of pediatric hypertension could enhance clinical care. The goal of this proposal is to create a registry of patients with hypertension to better enable research into this important disease. This patient registry will enhance the investigators ability to quickly collect and analyze data for research studies.

Read the detailed description

The investigators will include all subjects evaluated at the Brenner Children's Hospital Pediatric Nephrology clinic since January 1st, 2013 with a diagnosis of high blood pressure confirmed with three separate blood pressure measurements >=90th percentile for age, sex, and height, or >120/80 mmHg. The investigators will exclude patients whose initial evaluation occurred on or after their 18th birthday.

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Conditions studied

  • Hypertension
  • Pediatric Disorder

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Keywords

  • Hypertension
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Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects that are patients in the Brenner Children's Hospital Pediatric Nephrology Clinic or Emory University Pediatric Nephrology with a confirmed diagnosis of high blood pressure.

Inclusion criteria

  • Patients at one of the following : Wake Forest Baptist Health Brenner Children's Hospital Pediatric Nephrology clinic Emory University Pediatric Nephrology
  • Diagnosis of hypertension confirmed with three separate blood pressure measurements
  • Diagnosis after January 2013
  • >90th percentile for age, sex, height, or >120/80.

Exclusion criteria

Exclusion Criteria:

  • Patients whose initial evaluation occurred on or after their 18th birthday.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
179 participants (actual)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Retrospective cohort

    The cohort of patients seen prior to the implementation of a standardized clinical management protocol on 10/01/2017 whose data is collected retrospectively.

  • Prospective cohort

    The cohort of patients seen initially seen after implementation of a standardized clinical management protocol on 10/01/2017 whose data is collected prospectively.

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What researchers measure

Primary outcomes

  1. Blood pressure

    Auscultated blood pressure measurements in clinic

    Time frame: 10 years

  2. Left ventricular hypertrophy

    Left ventricular hypertrophy and other cardiac structural/function changes on echocardiograms

    Time frame: 10 years

  3. Albuminuria

    Urinary albumin-to-creatinine (\>30 mg/g)

    Time frame: 10 years

Secondary outcomes

  1. Ambulatory blood pressure

    Ambulatory blood pressure monitoring data

    Time frame: 10 years

  2. Renal function

    Glomerular filtration rate

    Time frame: 10 years

  3. Uric acid

    Serum uric acid

    Time frame: 10 years

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Study locations

2 sites
  • Emory University Pediatric Nephrology
    Atlanta, Georgia 30322, United States
  • Wake Forest University Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
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References and documents

Publications

  • Din-Dzietham R, Liu Y, Bielo MV, Shamsa F. High blood pressure trends in children and adolescents in national surveys, 1963 to 2002. Circulation. 2007 Sep 25;116(13):1488-96. doi: 10.1161/CIRCULATIONAHA.106.683243. Epub 2007 Sep 10. PubMed 17846287 ↗
  • Richey PA, Disessa TG, Somes GW, Alpert BS, Jones DP. Left ventricular geometry in children and adolescents with primary hypertension. Am J Hypertens. 2010 Jan;23(1):24-9. doi: 10.1038/ajh.2009.164. Epub 2009 Oct 22. PubMed 19851297 ↗
  • King JT Jr, DiLuna ML, Cicchetti DV, Tsevat J, Roberts MS. Cognitive functioning in patients with cerebral aneurysms measured with the mini mental state examination and the telephone interview for cognitive status. Neurosurgery. 2006 Oct;59(4):803-10; discussion 810-1. doi: 10.1227/01.NEU.0000232666.67779.41. PubMed 17038944 ↗
  • Washburn LK, Nixon PA, Russell GB, Snively BM, O'Shea TM. Preterm Birth Is Associated with Higher Uric Acid Levels in Adolescents. J Pediatr. 2015 Jul;167(1):76-80. doi: 10.1016/j.jpeds.2015.03.043. Epub 2015 Apr 11. PubMed 25868431 ↗
  • Feig DI, Soletsky B, Johnson RJ. Effect of allopurinol on blood pressure of adolescents with newly diagnosed essential hypertension: a randomized trial. JAMA. 2008 Aug 27;300(8):924-32. doi: 10.1001/jama.300.8.924. PubMed 18728266 ↗
  • Mazzali M, Hughes J, Kim YG, Jefferson JA, Kang DH, Gordon KL, Lan HY, Kivlighn S, Johnson RJ. Elevated uric acid increases blood pressure in the rat by a novel crystal-independent mechanism. Hypertension. 2001 Nov;38(5):1101-6. doi: 10.1161/hy1101.092839. PubMed 11711505 ↗
  • Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z, Wei R, Curtin LR, Roche AF, Johnson CL. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11. 2002 May;(246):1-190. PubMed 12043359 ↗
  • Schwartz GJ, Brion LP, Spitzer A. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clin North Am. 1987 Jun;34(3):571-90. doi: 10.1016/s0031-3955(16)36251-4. PubMed 3588043 ↗
  • Flynn JT, Daniels SR, Hayman LL, Maahs DM, McCrindle BW, Mitsnefes M, Zachariah JP, Urbina EM; American Heart Association Atherosclerosis, Hypertension and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Update: ambulatory blood pressure monitoring in children and adolescents: a scientific statement from the American Heart Association. Hypertension. 2014 May;63(5):1116-35. doi: 10.1161/HYP.0000000000000007. Epub 2014 Mar 3. No abstract available. PubMed 24591341 ↗
  • Khoury PR, Mitsnefes M, Daniels SR, Kimball TR. Age-specific reference intervals for indexed left ventricular mass in children. J Am Soc Echocardiogr. 2009 Jun;22(6):709-14. doi: 10.1016/j.echo.2009.03.003. Epub 2009 May 7. PubMed 19423289 ↗
  • Rademacher ER, Sinaiko AR. Albuminuria in children. Curr Opin Nephrol Hypertens. 2009 May;18(3):246-51. doi: 10.1097/MNH.0b013e3283294b98. PubMed 19276802 ↗

Study documents

  • Study protocol · Jan 3, 2019
  • Informed consent form · Aug 11, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03305562
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Oct 10, 2017
Start date
Sep 20, 2017
Primary completion
Jun 22, 2021
Completion
Jun 22, 2021
Last update
Jun 12, 2023

Study contacts

Andrew M South, MD MS
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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