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 Cohort
    Participants with newly diagnosed primary hypertension
  • Arm: Control Cohort
    Healthy participants with normal blood pressure

Primary Outcome Measure

Baseline Urine Angiotensin-(1-7)/Creatinine Ratio [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Health SciencesWinston-SalemNorth Carolina27157
Andrew M South, MD, MS
336-716-9640
Caroline B Lucas
336.713.8038
Andrew M South, MD, MS (PRINCIPAL_INVESTIGATOR)

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