RecruitingNot Applicable

Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)

United States125 participantsStarted 2021-05-19

Plain-language summary

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.

Who can participate

Age range

7 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA: HYPERTENSION COHORT * 7-18 years of age at time of enrollment * Confirmed new diagnosis of primary hypertension: no identifiable secondary cause, referred to hypertension or nephrology clinic * Age \<13 years: BP ≥95th %ile or ≥130/80 mmHg (whichever is lower) * Age ≥13 years: BP ≥130/80 mmHg * Participants and their caregivers must be willing and able to commit to completing the study assessments EXCLUSION CRITERIA: HYPERTENSION COHORT * \<7 years or \>18 years of age at time of enrollment * BP confirmed as normal or in the elevated BP category based on ≥3 prior office BP measurements on separate days; * Age \<13 years: BP \<95th %ile or \<130/80 mmHg (whichever is lower) * Age ≥13 years: BP \<130/80 mmHg * A confirmed secondary cause of hypertension * Confounding medical condition (heart or kidney disease \[except hypertension-associated heart changes on echocardiogram or albuminuria\], vascular/inflammatory disease, or diabetes) * Inability to complete study assessments * Non-English/Spanish speakers * Current pregnancy * Ward of the State INCLUSION CRITERIA: CONTROL COHORT * 7-18 years of age at time of enrollment * Normal BP based on ≥3 prior office BP measurements on separate days; * Age \<13 years: BP \<90th %ile or \<120/80 mmHg (whichever is lower) * Age ≥13 years: BP \<120/80 mmHg * Participants and their caregivers must be willing and able to commit to completing the study assessments EXCLUSION CRITERIA: CONTROL COHORT * \<…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Baseline Urine Angiotensin-(1-7)/Creatinine Ratio

Timeframe: Baseline

Change in Urine Angiotensin-(1-7)/Creatinine Ratio

Timeframe: Baseline through 2 years

Baseline Urine Angiotensin II/Angiotensin-(1-7) Ratio

Timeframe: Baseline

Change in Urine Angiotensin II/Angiotensin-(1-7) Ratio

Timeframe: Baseline through 2 years

Baseline Plasma Angiotensin-(1-7) Level

Timeframe: Baseline

Change in Plasma Angiotensin-(1-7) Level

Timeframe: Baseline through 2 years

Baseline Plasma Angiotensin II/Angiotensin-(1-7) Ratio

Timeframe: Baseline

Trial details

NCT IDNCT04752293

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Andrew M South, MD, MS

336.716.9640 asouth@wakehealth.edu

View on ClinicalTrials.gov More Hypertension trials

Plain-language summary

Who can participate

Age range

7 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Baseline Urine Angiotensin-(1-7)/Creatinine Ratio

Timeframe: Baseline

Change in Urine Angiotensin-(1-7)/Creatinine Ratio

Timeframe: Baseline through 2 years

Baseline Urine Angiotensin II/Angiotensin-(1-7) Ratio

Timeframe: Baseline

Change in Urine Angiotensin II/Angiotensin-(1-7) Ratio

Timeframe: Baseline through 2 years

Baseline Plasma Angiotensin-(1-7) Level

Timeframe: Baseline

Change in Plasma Angiotensin-(1-7) Level

Timeframe: Baseline through 2 years

Baseline Plasma Angiotensin II/Angiotensin-(1-7) Ratio

Timeframe: Baseline