Genetic Information for High Blood Pressure

(PRISM-BP Trial)

Overseen By Nehal Vekariya, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Antihypertensives

Disqualifiers: Cardiovascular disease, BMI extremes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people manage high blood pressure. It tests whether sharing genetic information about blood pressure risk can motivate healthier lifestyle changes. Participants will receive either standard care or their genetic risk score (SBP PRS) along with special counseling. This trial suits adults under 55 with high blood pressure and poor cardiovascular health. The goal is to determine if this approach lowers blood pressure and improves overall health. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could transform high blood pressure management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using more than two types of blood pressure medications, you may not be eligible to participate.

What prior data suggests that delivering SBP PRS information is safe for participants?

Research shows that the systolic blood pressure polygenic risk score (SBP PRS) is generally safe. This method uses genetic information to predict a person's risk of high blood pressure and related health issues. Studies have not reported any safety concerns or side effects from using SBP PRS. Instead, they highlight the potential benefits of this genetic tool in improving treatment decisions and health outcomes for those with high blood pressure.

Since this trial is in the "Not Applicable" phase, SBP PRS is likely used for observation rather than testing a new drug or device. The focus is on understanding how genetic information can help manage blood pressure, which usually involves minimal risk. Participants receive structured genomic counseling to understand their risk score and use this information to make healthier lifestyle choices. This process is supportive and educational, enhancing safety by empowering participants with knowledge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SBP PRS treatment for high blood pressure because it leverages the power of personalized medicine. Unlike standard treatments that use a one-size-fits-all approach, this method provides participants with a personalized polygenic risk score (PRS) based on their genetic information. This score, combined with structured genomic counseling, aims to enhance understanding and motivation for lifestyle changes. By tailoring the treatment to each person's unique genetic makeup, it has the potential to significantly improve blood pressure control and overall cardiovascular health.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

This trial will compare routine clinical care with the use of a genetic score for systolic blood pressure (SBP) to predict blood pressure levels and the risk of heart problems. Participants in the "SBP PRS Dissemination" arm will receive their personalized SBP polygenic risk score (PRS) and structured genomic counseling, which may encourage healthier lifestyle choices and improve blood pressure management. Research has shown that using a genetic score can enhance predictions when combined with other health information and has been linked to patient responses to certain blood pressure medications, such as chlorthalidone. While the research is promising, it remains in the early stages, and further studies are needed to confirm these benefits for everyone. Participants in the "Routine Clinical Care" arm will receive standard care without the genetic score or counseling during the study. ^{1 6 7 8 9}

Who Is on the Research Team?

Pankaj Arora, MD, FAHA

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for young and middle-aged adults aged 18-55 with high blood pressure and poor cardiovascular health. Participants should be interested in how their genetic risk affects their health. People who don't meet the age requirement, have good cardiovascular health, or are not at risk of hypertension cannot join.

Inclusion Criteria

Able to provide informed consent

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

Exclusion Criteria

Moderate or severe anxiety (Beck Anxiety Inventory [BAI] score >16)

Body mass index (BMI) <18.5 kg/m² or >45 kg/m²

Baseline office SBP >160 mm Hg or DBP >100 mm Hg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Baseline Assessment

Comprehensive baseline health assessment including genotyping, computation of SBP PRS, and measurement of key health constructs

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either routine clinical care or SBP PRS results with structured genomic counseling

12 months

4 visits (in-person, quarterly)

Follow-up

Participants are monitored for changes in systolic blood pressure and health behaviors

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SBP PRS

Trial Overview The study tests if knowing your genetic risk score for high blood pressure can help you improve your lifestyle and lower your blood pressure. Half the participants will get regular care; the other half will also receive their polygenic risk score and counseling based on it.

How Is the Trial Designed?

Group I: SBP PRS Dissemination Experimental Treatment 1 Intervention

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.

Group II: Routine Clinical Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A new risk estimation tool was developed using data from 8760 participants in the Systolic Blood Pressure Intervention Trial (SPRINT) to compare the risks of cardiovascular events and acute kidney injury (AKI) between intensive and standard blood pressure treatments.

The tool, validated with high accuracy (areas under the curve of 0.70 for cardiovascular outcomes and 0.77 for AKI), helps identify patients who may benefit most from intensive blood pressure control while considering the potential risks of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Easy-to-use tool for evaluating the elevated acute kidney injury risk against reduced cardiovascular disease risk during intensive blood pressure control. Venäläinen, MS., Klén, R., Mahmoudian, M., et al.[2021]

In a study of 6427 older patients (average age 80) with hypertension, the best cardiovascular outcomes were observed in those with an average systolic blood pressure (SBP) of 120-129 mmHg, indicating a J-shaped relationship between SBP and adverse events.

Maintaining an SBP of less than 130 mmHg was linked to improved health outcomes without significant safety issues, supporting the recommendation to target this level in older patients if they can tolerate it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular outcomes according to on-treatment systolic blood pressure in older hypertensive patients: a multicenter cohort using a common data model. Kim, JH., Joo, HJ., Chung, SH., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11581630/

Utility of a Systolic Blood Pressure Polygenic Risk Score ... While there has been moderate success using PRS for predicting HTN and cardiovascular events, using an SBP PRS for predicting AHT efficacy has ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCGEN.124.005048

Development and Validation of Polygenic Risk Scores for ... This study aimed to develop and evaluate PRS for blood pressure (BP) traits in continental African populations and investigate how African genetic diversity ...

3. nature.com nature.com/articles/s41598-024-79683-7

Assessing the predictive efficacy of European-based ... This study evaluates the predictive efficacy of a systolic blood pressure (SBP) polygenic risk score (PRS), derived from the UK Biobank data, in two Brazilian ...

4. medrxiv.org medrxiv.org/content/10.1101/2025.06.30.25330577v1.full.pdf

Pathway-Specific Polygenic Risk Scores for Blood ... Results: In combined pathways analysis, PRS predicted risk better than base models fitted with only sex, age, and principal components. Compared ...

5. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2024/10/29/04/03/utility-of-a-systolic-blood-pressure

Systolic BP Polygenic Risk Score With Chlorthalidone ... This study reports that the SBP PRS was associated with SBP response to chlorthalidone, but not lisinopril.

6. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001077

Polygenic Risk Scores for Cardiovascular Disease In this scientific statement, we review the contemporary science, clinical considerations, and future challenges for polygenic risk scores for cardiovascular ...

7. nature.com nature.com/articles/s43856-025-00981-w

Appraisal of multiple polygenic risk scores to estimate the ... Polygenic risk scores (PRS) could help to identify individuals with a high genetic risk profile for coronary artery disease (CAD).

8. mdpi.com mdpi.com/2073-4425/13/8/1473

Life-Course Associations between Blood Pressure-Related ... In Black participants, each standard deviation increase in SBP and DBP PRS conferred a 38% (p = 0.009) and 22% (p = 0.02) increased risk of hypertension and a ...

9. uab.edu uab.edu/news/research-innovation/study-uncovers-the-role-of-polygenic-risk-scores-in-hypertension-management

Research & Innovation | UAB News UAB researchers explore how polygenic risk scores can refine treatment decisions for patients with high blood pressure.Physician-scientists from ...