Actively Recruiting
Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure
Led by University of Alabama at Birmingham · Updated on 2025-09-03
300
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
In a multi-ethnic population, a genome-wide polygenic risk score (PRS) for systolic blood pressure (SBP), incorporating over one million common genetic variants, predicts blood pressure (BP) traits and the risk of adverse cardiovascular events beyond traditional risk factors. Delivering SBP PRS information to young and middle-aged adults with hypertension (HTN) and poor cardiovascular health (CVH) may enhance their motivation to adopt healthier lifestyles, improve blood pressure control, and ultimately reduce the risk of future cardiovascular disease (CVD). This randomized controlled trial will assess the impact of SBP PRS disclosure and theory-based genomic counseling on systolic blood pressure and health behaviors. A total of 300 adults aged 18-55 years will be enrolled and randomized to receive either routine clinical care or SBP PRS results with structured genomic counseling based on the Health Belief Model (HBM). Participants will be followed for 12 months. The primary outcome is change in 24-hour mean SBP from baseline to one year. Secondary outcomes include changes in physical activity, diet, medication adherence, smoking, lipid and glucose levels, and body composition. The study will also evaluate how behavior change is influenced by health beliefs, including perceived risk and self-efficacy. This study aims to advance the use of genomic tools in hypertension management and cardiovascular disease prevention.
CONDITIONS
Official Title
Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years (inclusive) at the time of screening.
- Diagnosis of hypertension defined by 2017 ACC/AHA guidelines, with resting office systolic blood pressure of 130-160 mm Hg or diastolic blood pressure of 80-100 mm Hg, or current use of blood pressure medication.
- Poor cardiovascular health, defined as Life's Essential 8 score less than 50.
- Willing and able to undergo 24-hour ambulatory blood pressure monitoring to confirm hypertension.
- Able to provide informed consent.
You will not qualify if you...
- History of cardiovascular disease such as myocardial infarction, angina, cardiac arrhythmia, coronary heart disease, heart failure, stroke, or transient ischemic attack.
- Body mass index below 18.5 kg/m² or above 45 kg/m².
- Baseline office systolic blood pressure over 160 mm Hg or diastolic blood pressure over 100 mm Hg.
- Use of more than two classes of antihypertensive medications.
- Not meeting hypertension criteria based on 24-hour ambulatory blood pressure monitoring.
- Pregnant or breastfeeding.
- Estimated glomerular filtration rate below 60 mL/min/1.73 m².
- Urine albumin-to-creatinine ratio 30 mg/g or higher.
- Liver enzyme levels more than three times the normal upper limit.
- Significant psychiatric illness.
- Moderate or severe anxiety with a Beck Anxiety Inventory score over 16.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
N
Nehal Vekariya, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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