RecruitingNot ApplicableNCT06962488

Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure

Clinical Implementation of Blood Pressure Polygenic Risk Score

Sponsor

University of Alabama at Birmingham

Enrollment

300 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Hypertension Atherosclerotic Cardiovascular Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a polygenic risk score — a DNA-based tool that estimates an individual's inherited risk for high blood pressure based on their genes — can be used to better identify young and middle-aged adults who would benefit most from early blood pressure management. Participants will undergo genetic testing and blood pressure monitoring. **You may be eligible if...** - You are between 18 and 55 years old - You have been diagnosed with hypertension, OR your blood pressure is in the elevated range (systolic 130–160 mmHg or diastolic 80–100 mmHg), OR you are currently taking blood pressure medication - Your overall cardiovascular health score is below 50 (indicating poor heart health) - You are willing to wear a 24-hour blood pressure monitor to confirm your diagnosis **You may NOT be eligible if...** - You have a history of heart attack, stroke, heart failure, or other cardiovascular disease - Your BMI is below 18.5 or above 45 - You take more than two types of blood pressure medication - You have significant kidney disease or liver problems - You are pregnant or breastfeeding - You have significant anxiety or psychiatric illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALRegular 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.

BEHAVIORALSBP 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.