Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-18
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

<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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

125 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator