Actively Recruiting
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
Led by Wake Forest University Health Sciences · Updated on 2025-12-11
125
Participants Needed
1
Research Sites
288 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 7 to 18 years at enrollment
- Newly diagnosed primary hypertension with no secondary cause for hypertension
- Blood pressure at or above the 95th percentile or 130/80 mmHg for children under 13 years
- Blood pressure at or above 130/80 mmHg for children 13 years and older
- Willing and able to complete study assessments (both hypertension and control cohorts)
- Normal blood pressure for control participants based on at least three prior measurements
- For control cohort: blood pressure below the 90th percentile or 120/80 mmHg for children under 13 years
- For control cohort: blood pressure below 120/80 mmHg for children 13 years and older
You will not qualify if you...
- Younger than 7 or older than 18 years at enrollment
- Blood pressure confirmed normal or elevated but not meeting hypertension criteria for hypertension cohort
- Blood pressure elevated or hypertensive for control cohort or history of hypertension
- Secondary cause of hypertension
- Heart or kidney disease (except hypertension-related changes), vascular or inflammatory disease, or diabetes
- Unable to complete study assessments
- Non-English or non-Spanish speakers
- Current pregnancy
- Ward of the State
AI-Screening
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Trial Site Locations
Total: 1 location
1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
A
Andrew M South, MD, MS
CONTACT
C
Caroline B Lucas
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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