Status:
RECRUITING
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypertension
Left Ventricular Hypertrophy
Eligibility:
All Genders
7-18 years
Brief 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 k...
Detailed Description
This longitudinal prospective cohort study is recruiting children and adolescents aged 7-18 years with newly diagnosed primary hypertension over a 2-year period from the Hypertension and Pediatric Nep...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04752293
Start Date
May 19 2021
End Date
December 1 2026
Last Update
December 11 2025
Active Locations (1)
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1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157