Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure

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 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

• Hypertension
• Atherosclerotic Cardiovascular Disease

Interventions

BEHAVIORAL

Regular Care

Educational brochures and lifestyle guidance on blood pressure control, medication adherence, physical activity, and healthy diet, provided at baseline only. No additional counseling or genetic risk disclosure will occur during the 12-month intervention period.

BEHAVIORAL

SBP PRS Dissemination

Participants receive individualized SBP PRS reports and structured genomic counseling sessions delivered by trained genetic counselors. Counseling addresses key constructs of the Health Belief Model, including perceived susceptibility, severity, and benefits of behavior change, with an emphasis on lifestyle modification and medication adherence.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Pankaj Arora, MD, FAHA · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2030-03-31

Completion

2030-07-31

Countries

• United States

Study Locations