Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Alabama at Birmingham
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Regular Care
BehavioralEducational 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
BehavioralParticipants 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: SBP PRS DisseminationExperimental treatment 1 intervention
Group B: Routine Clinical CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Mean 24-Hour Systolic Blood Pressure
The difference in the 24-hour mean systolic BP between the two study groups at 1 year, adjusted for baseline.
Time frame
1 yearSecondary outcomes
1
Change in Physical Activity Levels
Physical activity levels in MET·hr-1·wk-1 estimated using 7-day actigraphy. The difference in the physical activity levels (MET·hr-1·wk-1) between the two study groups at 1 year, adjusted for baseline.
Time frame
1 year2
Change in Healthy Diet Index Score
The USDA Healthy Eating Index (HEI-2015) will be used to estimate changes in diet quality. The HEI score ranges from 0 to 100, with higher scores indicating better adherence to the Dietary Guidelines for Americans (i.e., better diet quality). The outcome measure will be the difference in HEI scores between the two study groups at 1 year, adjusted for baseline
Time frame
1 year3
Change in Medication Adherence
Medication adherence will be assessed using the Medication Adherence Report Scale (MARS-5). The MARS-5 scale has a score range from 5 to 25, with higher scores indicating better adherence. The outcome measure will be the difference in MARS-5 scores between the two study groups at 1 year, adjusted for baseline
Time frame
1 year4
Change in Ambulatory Blood Pressure Parameters
The difference in the 24-hour mean diastolic BP, daytime systolic BP, daytime diastolic BP, nighttime systolic BP, and nighttime diastolic BP between the two study groups at 1 year, adjusted for baseline.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov