Sex Differences in the Association of Multiethnic Genome-Wide Blood Pressure Polygenic Risk Score With Population-Level Systolic Blood Pressure Trajectories.
Naman S Shetty, Akhil Pampana, Nirav Patel...
https://pubmed.ncbi.nlm.nih.gov/38372177Actively Recruiting
Phase Not Applicable
Age: 18Years - 55Years
All Genders
ID06962488
Clinical Implementation of Blood Pressure Polygenic Risk Score A Randomized Trial Evaluating Genetic Risk Disclosure and Counseling in Adults with Hypertension
Led by University of Alabama at Birmingham · Updated on 2025-09-03
300
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of sharing a genome-wide polygenic risk score (PRS) for systolic blood pressure (SBP) combined with genomic counseling on blood pressure control and health behaviors in adults aged 18 to 55 years with hypertension and poor cardiovascular health. This randomized controlled trial aims to improve lifestyle choices, medication adherence, and ultimately reduce cardiovascular disease risk by using genetic information alongside traditional risk factors. The study will follow 300 participants from diverse backgrounds for 12 months to assess blood pressure changes and related health behaviors. Participants will be randomly assigned to one of two groups: one group will receive routine clinical care with educational materials on blood pressure and lifestyle management; the other group will receive their personalized SBP PRS results along with structured genomic counseling sessions based on the Health Belief Model. Counseling is provided at baseline and during follow-up visits every three months by trained genetic counselors. The study includes baseline genotyping, computation of SBP PRS, and stratification by race, sex, and genetic risk level. During the study, participants will undergo comprehensive evaluations including 24-hour ambulatory blood pressure monitoring, assessments of physical activity using 7-day actigraphy, dietary history, medication adherence, smoking status, lipid and glucose levels, body composition, anxiety levels, and quality of life surveys. Researchers will track changes in systolic blood pressure as the primary outcome, alongside secondary outcomes related to health behaviors and biological measures. The study also explores how health beliefs influence behavior changes. Follow-up lasts 12 months, with an end-of-study visit offering genomic counseling to routine care participants.
CONDITIONS
Brief Title
Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure
Who Can Participate
Age: 18Years - 55Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years (inclusive) at the time of screening
- Diagnosis of hypertension by 2017 ACC/AHA guidelines with resting office SBP 130-160 mm Hg, DBP 80-100 mm Hg, or current use of antihypertensive medication
- Poor cardiovascular health defined as Life's Essential 8 score below 50
- Willing and able to undergo 24-hour ambulatory blood pressure monitoring (ABPM)
- Able to provide informed consent
You will not qualify if you...
- History of cardiovascular disease including myocardial infarction, angina, cardiac arrhythmia, coronary heart disease, heart failure, stroke, or transient ischemic attack
- Body mass index (BMI) less than 18.5 or greater than 45 kg/m²
- Baseline office SBP greater than 160 mm Hg or DBP greater than 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) below 60 mL/min/1.73 m²
- Urine albumin-to-creatinine ratio 30 mg/g or higher
- Hepatic transaminase levels more than three times the upper limit of normal
- Significant psychiatric illness assessed by Global Health Questionnaire-12
- Moderate or severe anxiety with Beck Anxiety Inventory score greater than 16
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessment and Randomization
Duration - Approximately 2 weeks from screening to randomization
Participants undergo genotyping, comprehensive health assessments, and complete questionnaires before being randomized to either routine care or SBP PRS dissemination with genetic counseling.
1 baseline visit (in-person)
Intervention Period
Duration - 12 months
Participants receive either routine clinical care with educational materials or SBP PRS results with structured genomic counseling sessions focusing on health behavior change.
Baseline visit plus quarterly (every 3 months) in-person follow-up visits for counseling in the SBP PRS dissemination arm; routine care participants receive educational materials at baseline only
End-of-Study Visit and Optional Counseling
Duration - 1 visit at 12 months
Participants complete final assessments. Those in the routine care arm are offered their SBP PRS results and optional genomic counseling.
1 end-of-study visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
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Research Team
N
Nehal Vekariya, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Sex Differences in the Association of Genome-Wide Systolic Blood Pressure Polygenic Risk Score With Hypertension.
Naman S Shetty, Akhil Pampana, Nirav Patel...
https://pubmed.ncbi.nlm.nih.gov/37807951