HypertensionPRISM-BPNCT06962488
Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure
A study testing Regular Care and SBP PRS Dissemination in people with Hypertension and Atherosclerotic Cardiovascular Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypertension, Atherosclerotic Cardiovascular Disease
- What is being tested?
- Regular Care and SBP PRS Dissemination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Nehal Vekariya, MS, 205-934-7173, nvekariya@uabmc.edu
Pankaj Arora, MD
About this study
Official title: Clinical Implementation of Blood Pressure Polygenic Risk Score
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.
Read the detailed description
This parallel-arm, randomized clinical trial is designed to assess the change in SBP following BP PRS dissemination and genomic counseling. Investigators will enroll 300 young and middle-aged adults (age: 18-55 years; 50% females; 50% non-White) with HTN [stratified by race, sex, and SBP PRS group (high vs. low/intermediate)] and poor CVH [American Heart Association's (AHA) Life Essential 8 Score: 0-50]. Participants will be randomized to A) routine clinical care (N=150), or B) SBP PRS dissemination (regular care + SBP PRS delivery and genetic counseling; N=150). After obtaining informed consent, the eligible participants will undergo genotyping and computation of their genome-wide SBP PRS. The SBP PRS results will be available within 10-15 days of screening. Participants will then be randomized in a 1:1 manner [stratified by sex, racial/ethnic group (White vs. non-White), and SBP PRS (high vs. low/intermediate)] to either the SBP PRS dissemination arm or the routine care arm. Participants will undergo a comprehensive baseline health assessment, including measurement of key HBM constructs, using the recently developed Attitudes and Beliefs about the CVD (ABCD) Risk Questionnaire, a 26-item instrument validated in the clinical setting with four subscales: perceived risk of heart attack/stroke, perceived benefits and intentions to exercise, healthy eating intentions, and perceived benefits and intentions to reducing smoking. Investigators will also assess the perceived severity of CVD, perceived barriers to prevention behaviors, and self-efficacy to perform preventive behaviors using subscales previously assessed for content and face validity by an expert review panel and patient focus groups. Physical activity status and sleep duration (using 7-day Actigraphy), detailed dietary history [using the United States Department of Agriculture (USDA) Healthy Eating Index and collected through the validated Nutrition Coordinating Center Nutrition Data System for Research (NCC NDSR) dietary assessment tool], health-related quality of life [using 36-Item Short Form Survey (SF-36), and the Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life-14 (HRQOL-14)], medication adherence using the Medication Adherence Rating Scale (MARS), 24-hour ambulatory blood pressure monitoring (ABPM), current health behaviors (smoking, alcohol, recreational drugs), and other cardiometabolic health parameters [lipid profile, hemoglobin A1c (HbA1c), body mass index (BMI), and body composition), and anxiety [using the Beck Anxiety Inventory (BAI)].
- Being tested
- Regular Care, SBP PRS Dissemination
- Keywords
- Systolic Blood Pressure, Polygenic Risk Score, Genomic Counseling, Health Belief Model, Cardiovascular Health
- Medical subject headings
- Hypertension, Atherosclerosis, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular CareBehavioural
Educational 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 DisseminationBehavioural
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| SBP PRS Dissemination | Experimental | 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. Receives: Behavioral: SBP PRS Dissemination |
| Routine Clinical Care | Active comparator | 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. Receives: Behavioral: Regular Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (14)
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.
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
Change in Lipid Profile
The difference in the low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride, and total cholesterol levels between the two study groups at 1 year, adjusted for baseline.
Measured: 1 year
Change in Sleep Duration
The difference in the sleep duration estimated using 7-day actigraphy, between the two study groups at 1 year, adjusted for baseline.
Measured: 1 year
Change in Body Mass Index
The difference in the body mass index between the two study groups at 1 year, adjusted for baseline.
Measured: 1 year
Change in Fat Mass
The difference in the fat mass between the two study groups at 1 year, adjusted for baseline.
Measured: 1 year
Change in Lean Mass
The difference in the lean mass between the two study groups at 1 year, adjusted for baseline.
Measured: 1 year
Change in Health Belief Model Constructs
The difference in the Health Belief Model constructs, measured using standardized questionnaires, between the two study groups at 1 year, adjusted for baseline.
Measured: 1 year
Change in Smoking Behavior
Estimated as the number of cigarettes per week. The difference in the number of cigarettes per week between the two study groups at 1 year, adjusted for baseline.
Measured: 1 year
Change in Health-Related Quality of Life (SF-36)
Assessed using the 36-Item Short Form Survey (SF-36). The SF-36 produces scores ranging from 0 to 100, with higher scores indicating better quality of life. The difference between study groups at 1 year will be assessed, adjusted for baseline.
Measured: 1 year
Change in Health-Related Quality of Life (CDC HRQOL-14)
Assessed using the Centers for Disease Control and Prevention Health-Related Quality of Life 14-item measure (CDC HRQOL-14). The number of physically and mentally unhealthy days is recorded, with higher numbers indicating worse quality of life. The difference between study groups at 1 year will be assessed, adjusted for baseline.
Measured: 1 year
Change in Anxiety
Anxiety will be assessed using the Beck Anxiety Inventory (BAI). The BAI scores range from 0 to 63, with higher scores indicating greater severity of anxiety symptoms. The outcome measure will be the difference in BAI scores between the two study groups at 1 year, adjusted for baseline.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Aug 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Pankaj Arora, MD, University of Alabama at Birmingham
- Investigators
- Pankaj Arora, MD, FAHA, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962488
- Sponsor's protocol ID
- IRB-300014760
- Other IDs
- R01HL176882
- Acronym
- PRISM-BP
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shetty NS, Pampana A, Patel N, Yerabolu K, Patel G, Irvin MR, Natarajan P, Lin HJ, Guo X, Rich SS, Rotter JI, Li P, Arora G, Arora P. Sex Differences in the Association of Multiethnic Genome-Wide Blood Pressure Polygenic Risk Score With Population-Level Systolic Blood Pressure Trajectories. Circ Genom Precis Med. 2024 Apr;17(2):e004515. doi: 10.1161/CIRCGEN.123.004515. Epub 2024 Feb 19. No abstract available.
PubMed 38372177Shetty NS, Pampana A, Patel N, Li P, Yerabolu K, Gaonkar M, Arora G, Arora P. Sex Differences in the Association of Genome-Wide Systolic Blood Pressure Polygenic Risk Score With Hypertension. Circ Genom Precis Med. 2023 Dec;16(6):e004259. doi: 10.1161/CIRCGEN.123.004259. Epub 2023 Oct 9. No abstract available.
PubMed 37807951
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implementation of Blood Pressure Polygenic Risk Score
- ClinicalTrials.gov ID
- NCT06962488
- Acronym / sponsor ID
- PRISM-BP / IRB-300014760
- Keywords
- Systolic Blood Pressure, Polygenic Risk Score, Genomic Counseling, Health Belief Model, Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This parallel-arm, randomized clinical trial is designed to assess the change in SBP following BP PRS dissemination and genomic counseling. Investigators will enroll 300 young and middle-aged adults (age: 18-55 years; 50% females; 50% non-White) with HTN [stratified by race, sex, and SBP PRS group (high vs. low/intermediate)] and poor CVH [American Heart Association's (AHA) Life Essential 8 Score: 0-50]. Participants will be randomized to A) routine clinical care (N=150), or B) SBP PRS dissemination (regular care + SBP PRS delivery and genetic counseling; N=150). After obtaining informed consent, the eligible participants will undergo genotyping and computation of their genome-wide SBP PRS. The SBP PRS results will be available within 10-15 days of screening. Participants will then be randomized in a 1:1 manner [stratified by sex, racial/ethnic group (White vs. non-White), and SBP PRS (high vs. low/intermediate)] to either the SBP PRS dissemination arm or the routine care arm. Participants will undergo a comprehensive baseline health assessment, including measurement of key HBM constructs, using the recently developed Attitudes and Beliefs about the CVD (ABCD) Risk Questionnaire, a 26-item instrument validated in the clinical setting with four subscales: perceived risk of heart attack/stroke, perceived benefits and intentions to exercise, healthy eating intentions, and perceived benefits and intentions to reducing smoking. Investigators will also assess the perceived severity of CVD, perceived barriers to prevention behaviors, and self-efficacy to perform preventive behaviors using subscales previously assessed for content and face validity by an expert review panel and patient focus groups. Physical activity status and sleep duration (using 7-day Actigraphy), detailed dietary history [using the United States Department of Agriculture (USDA) Healthy Eating Index and collected through the validated Nutrition Coordinating Center Nutrition Data System for Research (NCC NDSR) dietary assessment tool], health-related quality of life [using 36-Item Short Form Survey (SF-36), and the Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life-14 (HRQOL-14)], medication adherence using the Medication Adherence Rating Scale (MARS), 24-hour ambulatory blood pressure monitoring (ABPM), current health behaviors (smoking, alcohol, recreational drugs), and other cardiometabolic health parameters [lipid profile, hemoglobin A1c (HbA1c), body mass index (BMI), and body composition), and anxiety [using the Beck Anxiety Inventory (BAI)].
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBP PRS Dissemination | Experimental | Behavioral: SBP PRS DisseminationParticipants 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. |
| Routine Clinical Care | Active comparator | Behavioral: Regular CareParticipants 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 may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular CareEducational 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. | Behavioural | Routine Clinical Care |
| SBP PRS DisseminationParticipants 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. | Behavioural | SBP PRS Dissemination |
Primary outcome
Change in Mean 24-Hour Systolic Blood Pressure
Time frame: 1 year
The difference in the 24-hour mean systolic BP between the two study groups at 1 year, adjusted for baseline.
14 secondary outcomes
Change in Physical Activity Levels
Time frame: 1 year
Change in Healthy Diet Index Score
Time frame: 1 year
Change in Medication Adherence
Time frame: 1 year
Change in Ambulatory Blood Pressure Parameters
Time frame: 1 year
Change in Lipid Profile
Time frame: 1 year
Change in Sleep Duration
Time frame: 1 year
Change in Body Mass Index
Time frame: 1 year
Change in Fat Mass
Time frame: 1 year
Change in Lean Mass
Time frame: 1 year
Change in Health Belief Model Constructs
Time frame: 1 year
Change in Smoking Behavior
Time frame: 1 year
Change in Health-Related Quality of Life (SF-36)
Time frame: 1 year
Change in Health-Related Quality of Life (CDC HRQOL-14)
Time frame: 1 year
Change in Anxiety
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 38372177Shetty NS, Pampana A, Patel N, Yerabolu K, Patel G, Irvin MR, Natarajan P, Lin HJ, Guo X, Rich SS, Rotter JI, Li P, Arora G, Arora P. Sex Differences in the Association of Multiethnic Genome-Wide Blood Pressure Polygenic Risk Score With Population-Level Systolic Blood Pressure Trajectories. Circ Genom Precis Med. 2024 Apr;17(2):e004515. doi: 10.1161/CIRCGEN.123.004515. Epub 2024 Feb 19. No abstract available.
- Background: PubMed 37807951Shetty NS, Pampana A, Patel N, Li P, Yerabolu K, Gaonkar M, Arora G, Arora P. Sex Differences in the Association of Genome-Wide Systolic Blood Pressure Polygenic Risk Score With Hypertension. Circ Genom Precis Med. 2023 Dec;16(6):e004259. doi: 10.1161/CIRCGEN.123.004259. Epub 2023 Oct 9. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pankaj Arora, MD, FAHA principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Care and SBP PRS Dissemination in people with Hypertension and Atherosclerotic Cardiovascular Disease, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nehal Vekariya, MS (2059347173, nvekariya@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean 24-Hour Systolic Blood Pressure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06962488, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.