NCT04752293 Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
| NCT ID | NCT04752293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2021-05-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2021-05-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Andrew M South, MD, MS
PRINCIPAL INVESTIGATOR
Wake Forest Health Sciences
Frequently Asked Questions
Who can join the NCT04752293 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 18 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04752293 currently recruiting?
Yes, NCT04752293 is actively recruiting participants. Contact the research team at asouth@wakehealth.edu for enrollment information.
Where is the NCT04752293 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT04752293 clinical trial?
NCT04752293 is sponsored by Wake Forest University Health Sciences. The principal investigator is Andrew M South, MD, MS at Wake Forest Health Sciences. The trial plans to enroll 125 participants.