Home › Trials › NCT06962488
Clinical trial Recruiting at 1 site Interventional Ages 18 to 55

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

Official title: Clinical Implementation of Blood Pressure Polygenic Risk Score

Run by University of Alabama at Birmingham · NCT06962488 · Data updated 2026-11-12

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.

More Hypertension trials

Quick facts

Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment300 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations1 site (Birmingham, Alabama)
StatusRecruiting
StartedAugust 1, 2025
Main results expectedMarch 31, 2030
Study endsJuly 31, 2030
Registry record updatedOctober 9, 2026
Trial IDNCT06962488 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: nvekariya@uabmc.edu
  • Phone: 2059347173

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Hypertension 1034Atherosclerotic Cardiovascular Disease 43University of Alabama at Birmingham 1432
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.