Recruiting

SBP PRS

Sponsor:

University of Alabama at Birmingham

Code:

NCT06962488

Conditions

Hypertension

Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Regular Care

SBP PRS Dissemination

Study Details

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 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

Study ID

NCT06962488

Start date

Aug 1, 2025

Status verified date

Sep, 2025

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: SBP PRS Dissemination

Participants randomized to this arm will receive their personalized SBP polygenic risk score (PRS), along with structured genomic counseling sessions guided by the Health Belief Model and routine clinical care. Counseling will be delivered by trained genetic counselors at baseline and during 3-monthly in-person follow-up visits. The counseling is designed to increase perceived susceptibility, reduce perceived barriers, and improve self-efficacy for health behavior change.

active comparator: Routine Clinical Care

Participants randomized to this arm will receive standard clinical care for hypertension, including educational materials on blood pressure control, lifestyle modification, and cardiovascular health. These materials will be adapted from the American Heart Association Life's Essential 8 and the ACC preventive cardiology toolkit. Participants will not receive SBP PRS results or genomic counseling during the study. At the end-of-study visit (12 months), participants in this group will be offered their SBP PRS results and optional genomic counseling.

Interventions

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.

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 outcome measure

  • Change in Mean 24-Hour Systolic Blood Pressure [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Nehal Vekariya, MS

2059347173nvekariya@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Nehal Vekariya, MS

205-934-7173nvekariya@uabmc.edu

Principal Investigator:

Pankaj Arora, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Sep 3, 2025

Last verified

Sep, 2025

Keywords

  • Systolic Blood Pressure
  • Polygenic Risk Score
  • Genomic Counseling
  • Health Belief Model
  • Cardiovascular Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-09-03.