Using a genetic blood-pressure risk score to guide care for adults with high blood pressure

Clinical Implementation of Blood Pressure Polygenic Risk Score

This trial will test whether giving adults aged 18–55 with hypertension and poor cardiovascular health their genetic risk score for systolic blood pressure plus structured genomic counseling helps them lower blood pressure and improve healthy habits over 12 months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT06962488 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel-arm trial enrolling 300 adults aged 18–55 with hypertension and poor cardiovascular health to test the impact of disclosing a genome-wide systolic blood pressure polygenic risk score (PRS) combined with structured genomic counseling versus routine clinical care. Participants will be genotyped and classified by SBP PRS (high vs. low/intermediate) and randomized 1:1 with stratification by sex and race, then followed for 12 months. The intervention arm receives SBP PRS results with counseling grounded in the Health Belief Model, while the control arm receives usual care; the primary outcome is change in systolic blood pressure. The trial emphasizes a multi-ethnic sample and uses ambulatory blood pressure monitoring to confirm hypertension at baseline.

Who should consider this trial

Good fit: Adults 18–55 years old with hypertension by 2017 ACC/AHA criteria, a Life's Essential 8 score below 50, willing to undergo 24-hour ambulatory blood pressure monitoring, and able to provide informed consent are ideal candidates.

Not a fit: People with prior cardiovascular disease, very high baseline blood pressure (office SBP >160 or DBP >100 mm Hg), pregnancy, BMI outside 18.5–45 kg/m², use of more than two antihypertensive drug classes, or those not confirmed hypertensive on 24-hour ABPM are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, providing SBP PRS information with targeted counseling could motivate healthier behaviors, improve blood pressure control, and reduce future cardiovascular risk.

How similar studies have performed: Polygenic risk scores for blood pressure have been shown to predict BP traits and cardiovascular risk beyond traditional factors, but randomized trials testing whether PRS disclosure plus counseling changes blood pressure or long-term outcomes are limited, making this an implementation-focused and relatively novel trial.

Eligibility criteria

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).

Where this trial is running

Birmingham, Alabama

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Principal investigator: Pankaj Arora, MD, FAHA — University of Alabama at Birmingham
• Study coordinator: Nehal Vekariya, MS

Conditions Hypertension; Atherosclerotic Cardiovascular Disease; Systolic Blood Pressure; Polygenic Risk Score; Genomic Counseling; Health Belief Model; Cardiovascular Health