Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure

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.

NCT Number	NCT06962488
Lead Sponsor	University of Alabama at Birmingham Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Hypertension, Atherosclerotic Cardiovascular Disease
Enrollment	300 participants
Start Date	2025-08-01
Primary Completion	2030-03-31 (estimated)
Study Completion	2030-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-03