Recruiting

Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure

ClinicalTrials.gov IDNCT06962488

PhaseNA

Enrollment300

SponsorUniversity of Alabama at Birmingham

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Hypertension, Atherosclerotic Cardiovascular Disease

About this study

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.

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.

Primary outcomes

Change in Mean 24-Hour Systolic Blood Pressure (1 year)

Eligibility information

Inclusion Criteria: * 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 Criteria: * 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).

Study locations

University of Alabama at Birmingham, Birmingham, Alabama 35294 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.