Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association.
Emelia J Benjamin, Salim S Virani, Clifton W Callaway...
https://pubmed.ncbi.nlm.nih.gov/29386200Actively Recruiting
Age: 7Years - 18Years
All Genders
Healthy Volunteers
ID04752293
Pediatric Hypertension and the Renin-Angiotensin System (PHRASE): The Role of Angiotensin-(1-7) in Hypertension and Heart and Kidney Damage in Children
Led by Wake Forest University Health Sciences · Updated on 2025-12-11
125
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how specific components of the renin-angiotensin-aldosterone system, uric acid, and klotho contribute to high blood pressure and related damage in children and adolescents aged 7 to 18 years. It compares children newly diagnosed with primary hypertension to healthy controls, investigating how these biological factors affect the heart, kidneys, blood vessels, and brain over time. The study focuses on the variability in disease traits and treatment responses using detailed biological and clinical measurements. Participants are divided into two groups: children with newly diagnosed primary hypertension and healthy children with normal blood pressure. Blood and urine samples are collected to analyze levels of various substances such as Ang-(1-7), ACE2, and uric acid. Blood pressure, heart function and structure, kidney function, autonomic nervous system function, and vascular function are measured at the start, after one year (for both groups), and after two years (for the hypertension group), allowing researchers to observe changes over time and responses to treatment. Throughout the study, participants undergo multiple assessments including blood and urine tests, blood pressure monitoring, echocardiograms, and measurements of autonomic and vascular function. These evaluations occur at baseline, one year, and two years to track health changes and treatment effects. The study also monitors changes in biomarkers and organ function to better understand hypertension's impact and guide future patient care. Participants and their caregivers are expected to commit to completing all assessments during the study period.
CONDITIONS
Brief Title
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
Who Can Participate
Age: 7Years - 18Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 7 and 18 years at enrollment
- New diagnosis of primary hypertension with no identifiable secondary cause for Hypertension Cohort
- For Hypertension Cohort: Blood pressure at or above 95th percentile or 130/80 mmHg (age under 13) or at or above 130/80 mmHg (age 13 or older)
- For Control Cohort: Normal blood pressure below 90th percentile or 120/80 mmHg (age under 13) or below 120/80 mmHg (age 13 or older)
- Participants and caregivers willing and able to complete all study assessments
You will not qualify if you...
- Younger than 7 or older than 18 years at enrollment
- For Hypertension Cohort: Blood pressure confirmed as normal or elevated but below hypertension threshold based on multiple measurements
- For Control Cohort: Elevated blood pressure or history of hypertension
- Confirmed secondary cause of hypertension
- Other heart or kidney diseases, vascular or inflammatory diseases, or diabetes (except hypertension-related heart changes or albuminuria)
- Inability to complete study assessments
- Non-English or non-Spanish speakers
- Current pregnancy
- Ward of the State
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline assessment
Participants undergo baseline assessments including blood and urine collection and measurements of blood pressure, heart, kidney, autonomic, and vascular function.
1 baseline visit (in-person)
Long-term Monitoring
Duration - Up to 2 years
Participants are followed over 2 years with repeat assessments to monitor changes in blood pressure, heart, kidney, autonomic, and vascular function and biomarkers related to hypertension.
Follow-up visits at year 1 and year 2 (in-person)
Trial Site Locations
Total: 1 location
1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
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Research Team
A
Andrew M South, MD, MS
C
Caroline B Lucas
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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