Clinical trial Recruiting at 1 site Observational Ages 7 to 18

Understanding pediatric hypertension and its effects on the body

Official title: Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE): The Role of Angiotensin-(1-7) in Hypertension and Hypertension-Induced Heart and Kidney Damage

Run by Wake Forest University Health Sciences · NCT04752293 · Data updated 2026-11-12

This study looks at how different factors related to blood pressure affect children aged 7-18 who have just been diagnosed with high blood pressure, to see how it impacts their health over two years.

Quick facts

Study typeObservational
Ages7 Years to 18 Years
SexAll
Enrollment125 (estimated)
SponsorWake Forest University Health Sciences
Academic / other
Locations1 site (Winston-Salem, North Carolina)
StatusRecruiting
StartedMay 19, 2021
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedDecember 11, 2025
Trial IDNCT04752293 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children and adolescents aged 7-18 years with a new diagnosis of primary hypertension.

Probably not a fit

Patients with secondary causes of hypertension or those outside the age range of 7-18 years may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the roles of various components of the renin-angiotensin-aldosterone system in children aged 7-18 with newly diagnosed primary hypertension. Over a two-year period, researchers will collect blood and urine samples and measure blood pressure, heart structure and function, kidney function, and other health indicators. The study aims to identify phenotypic and treatment response variability among participants and to explore the causal relationships between these components and target organ damage. Healthy control participants will also be recruited for comparison.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of pediatric hypertension, potentially reducing long-term health complications.

How similar studies have gone: While there have been studies on hypertension in children, this specific approach focusing on the renin-angiotensin-aldosterone system is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

* \<7 or \>18 years of age at time of enrollment
* Elevated BP or hypertension, 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
* History of elevated BP or hypertension
* Current use of BP-lowering medications
* Confounding medical condition (heart or kidney disease, vascular/inflammatory disease, or diabetes)
* Inability to complete study assessments
* Non-English/Spanish speakers
* Current pregnancy
* Ward of the State

Where it's running

  • Wake Forest Health Sciences
    Winston-Salem, North Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Andrew M South, MD, MS — Wake Forest Health Sciences
  • Study coordinator: Andrew M South, MD, MS
  • Email: asouth@wakehealth.edu
  • Phone: 336.716.9640

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.