Studies Blood Pressure and Hormone Changes in Children with High Blood Pressure
Follows children newly diagnosed with high blood pressure and checks their heart and kidney health.
Key facts
- Who runs it
- Wake Forest University Health Sciences
- Where
- Winston-Salem, United StatesSee the site
- Trial code
- Registry title
- Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
- Status
- Recruiting
- People taking part
- 125 people, planned
- Started
- 19 May 2021
- Expected to end
- Dec 2026
- Type of study
- Observational, 2 groups
- Record updated
- 11 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 7 to 18 with newly diagnosed primary high blood pressure, and also healthy children with normal blood pressure as a comparison group.
- Age
- 7 to 18 years.
- Sex
- All sexes can join.
- Disease stage
- Hypertension group: new diagnosis of primary high blood pressure with no identifiable secondary cause. Control group: normal blood pressure.
- Earlier treatment
- Control group: cannot be taking blood pressure-lowering medicines.
Main reasons for not taking part
- A confirmed secondary cause of high blood pressure
- Heart or kidney disease, vascular or inflammatory disease, or diabetes (some hypertension-related heart or kidney changes are allowed in the hypertension group)
- Current pregnancy
- Not able to complete the study assessments
- Not speaking English or Spanish
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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)
- <7 years or >18 years of age at time of enrollment
- <7 or >18 years of age at time of enrollment
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 18 years old?
Where in United States
- Wake Forest Health SciencesWinston-Salem, United StatesContact: Andrew M South, MD, MSTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Hypertension Cohort
Participants with newly diagnosed primary hypertension
- Control Cohort
Healthy participants with normal blood pressure
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Studies Blood Pressure and Hormone Changes in Children with High Blood PressureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04752293, who can take part
- Record updated
- 11 December 2025