Status:
RECRUITING
Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypertension
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
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 an...
Detailed Description
This parallel-arm, randomized clinical trial is designed to assess the change in SBP following BP PRS dissemination and genomic counseling. Investigators will enroll 300 young and middle-aged adults (...
Eligibility Criteria
Inclusion
- Age 18 to 55 years (inclusive) at the time of screening.
- Diagnosis of hypertension defined by 2017 ACC/AHA guidelines, as evidenced by Resting office systolic blood pressure (SBP) of 130-160 mm Hg or Resting office diastolic blood pressure (DBP) of 80-100 mm Hg or Current use of antihypertensive medication.
- Poor cardiovascular health, defined as Life's Essential 8 score \<50.
- Willing and able to undergo 24-hour ambulatory blood pressure monitoring (ABPM) to confirm hypertension.
- Able to provide informed consent.
Exclusion
- History of cardiovascular disease, including Myocardial infarction, Angina, Cardiac arrhythmia, Coronary heart disease, Heart failure, Stroke, or transient ischemic attack.
- Body mass index (BMI) \<18.5 kg/m² or \>45 kg/m².
- Baseline office SBP \>160 mm Hg or DBP \>100 mm Hg.
- Use of more than two antihypertensive medication classes.
- Not hypertensive based on 24-hour ABPM (per 2017 ACC/AHA criteria).
- Pregnant or breastfeeding.
- Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² (using CKD-EPI equation).
- Urine albumin-to-creatinine ratio ≥30 mg/g.
- Hepatic transaminase levels \>3× the upper limit of normal.
- Significant psychiatric illness (assessed via Global Health Questionnaire-12).
- Moderate or severe anxiety (Beck Anxiety Inventory \[BAI\] score \>16).
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06962488
Start Date
August 1 2025
End Date
July 31 2030
Last Update
September 3 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294