Pediatric Hypertension Registry (PHREG)
Conditions: Hypertension, Pediatric Disorder
Sponsor: Wake Forest University Health Sciences

PHREG - Pediatric Hypertension Registry 
Protocol 01/03/19 
PI Andrew M. South, MD, MS 
Study Coordinator Lauren Vannoy 
 
Background 
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 pediatric hypertension to better enable research into this important disease. This 
patient registry will enhance our ability to quickly collect and analyze data for research studies. 
 
Study Design 
Inclusion and Exclusion CriteriaWe will include all subjects evaluated at the Brenner Children’s 
Hospital Pediatric Nephrology clinic since January 1st, 2013 with a diagnosis of hypertension 1) 
confirmed with three separate blood pressure measurements ≥90th %ile for age, sex, and 
height, or ≥120/80 or 2) by ambulatory blood pressure monitoring with blood pressure mean 
<95th %ile, blood pressure load <25%, or nocturnal dipping <10%. We will also include patients 
from Brenner’s Enhanced Care Team database using the same criteria. We will exclude 
patients whose initial evaluation occurred on or after their 18th birthday. An additional site, 
Emory University Pediatric Nephrology will be using the same criteria to enroll subjects. 
 
Retrospective Assessment 
Brenner Children’s Hospital Pediatric Nephrology will utilize i2b2 to identify our retrospective 
hypertension cohort. We will search for diagnosis codes of hypertension and related terms to 
retrospectively identify patients to be entered into the database.  We anticipate a sample size of 
500 subjects to be identified retrospectively at each site. Additional study sites may use i2b2 to 
identify subjects or a similar cohort at its discretion. 
 
Prospective Assessment 
Sites will recruit from patients prospectively seen in their Pediatric Nephrology clinics with a 
diagnosis of hypertension. We will obtain parental consent and subject assent for all enrolled 
subjects. There are no study-specific assessments or visits. No patient biologic samples will be 
collected. We anticipate enrolling 200 subjects per year. 
 
Data Collection 
Clinical data will be collected from the electronic medical record, including sex, parent-reported 
race, height, weight, body mass index, age at diagnosis, age at each visit, and past medical and 
family histories. We will define overweight/obesity as a body mass index ≥85th %ile for age and 
sex. We will record systolic and diastolic blood pressure and results of ambulatory blood 
pressure monitoring. We will note antihypertensive medication type and dosage. We will record 
standard clinical laboratory values, including sodium, potassium, chloride, CO2, blood urea 
nitrogen, creatinine, uric acid, aspartate aminotransferase, alanine aminotransferase, lipid 
profile, vitamin D 25-OH, Hgb A1c, renin, aldosterone, thyroid stimulating hormone, free 
thyroxine, urine albumin, urine protein, urine creatinine, and presence of hematuria. We will 
calculate glomerular filtration rate to measure renal function standardized to age, sex, and 
height. We will record results of echocardiograms, renal ultrasounds, abdominal ultrasounds 

with elastography, and vesicoureterograms. Every subject will be assigned a study ID, and all 
data will be de-identified and stored securely ina RedCap database that will be shared across 
study sites and that can store site-specific patient data separately. 
 
 
 
References 
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