NCT04752293Recruiting
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE): The Role of Angiotensin-(1-7) in Hypertension and Hypertension-Induced Heart and Kidney Damage
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 125 (estimated)
- First submitted
- 21 Jan 2021
- Start date
- 19 May 2021
- Primary completion date
- Dec 2026
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT04752293
What you commit to
- Study type: Observational
- Planned participants: 125
- From 19 May 2021 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- Current use of BP-lowering medications
Other illness
- 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)
- History of elevated BP or hypertension
- Confounding medical condition (heart or kidney disease, vascular/inflammatory disease, or diabetes)
Age
- \<7 years or \>18 years of age at time of enrollment
- \<7 or \>18 years of age at time of enrollment
Other
- Inability to complete study assessments
- Non-English/Spanish speakers
- Current pregnancy
- Ward of the State
- Inability to complete study assessments
- Non-English/Spanish speakers
- Current pregnancy
- Ward of the State
Who the study is looking for
- 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
- 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
Age in the registry: 7 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.