Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
Part of paid clinical trials in Winston-Salem, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT04752293
- Status
- Recruiting
Conditions
- Albuminuria
- Angiotensin Hypertension
- Autonomic Dysfunction
- Autonomic Imbalance
- Blood Pressure Disorders
- Hypertension
- Kidney Diseases
- Kidney Dysfunction
- Kidney Injury
- Left Atrial Dilatation
- Left Ventricular Diastolic Dysfunction
- Left Ventricular Dysfunction
- Left Ventricular Hypertrophy
- Pediatric Kidney Disease
- Pediatric Obesity
- Proteinuria
- Sodium Urine High
- Uric Acid Retention
Eligibility Criteria
- Sex
- ALL
- Age
- 7 Years - 18 Years
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- May 19, 2021
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 125 participants (estimated)
Arms
- Arm: Hypertension CohortParticipants with newly diagnosed primary hypertension
- Arm: Control CohortHealthy participants with normal blood pressure
Primary Outcome Measure
Baseline Urine Angiotensin-(1-7)/Creatinine Ratio [ Time Frame: Baseline ]
Central Contacts
- Andrew M South, MD, MS336.716.9640
- Caroline B Lucas336.713.8038
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | Andrew M South, MD, MS (PRINCIPAL_INVESTIGATOR) |
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