RECRUITING

Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure

Talk to us

Conditions

HypertensionAtherosclerotic Cardiovascular DiseaseSystolic Blood PressurePolygenic Risk ScoreGenomic CounselingHealth Belief ModelCardiovascular Health

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Implementation of Blood Pressure Polygenic Risk Score

Quick Facts

Study Start:2025-08-01
Study Completion:2030-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06962488

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 to 55 years (inclusive) at the time of screening.
  2. * 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.
  3. * Poor cardiovascular health, defined as Life's Essential 8 score \<50.
  4. * Willing and able to undergo 24-hour ambulatory blood pressure monitoring (ABPM) to confirm hypertension.
  5. * Able to provide informed consent.
  1. * History of cardiovascular disease, including Myocardial infarction, Angina, Cardiac arrhythmia, Coronary heart disease, Heart failure, Stroke, or transient ischemic attack.
  2. * Body mass index (BMI) \<18.5 kg/m² or \>45 kg/m².
  3. * Baseline office SBP \>160 mm Hg or DBP \>100 mm Hg.
  4. * Use of more than two antihypertensive medication classes.
  5. * Not hypertensive based on 24-hour ABPM (per 2017 ACC/AHA criteria).
  6. * Pregnant or breastfeeding.
  7. * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² (using CKD-EPI equation).
  8. * Urine albumin-to-creatinine ratio ≥30 mg/g.
  9. * Hepatic transaminase levels \>3× the upper limit of normal.
  10. * Significant psychiatric illness (assessed via Global Health Questionnaire-12).
  11. * Moderate or severe anxiety (Beck Anxiety Inventory \[BAI\] score \>16).

Contacts and Locations

Study Contact

Nehal Vekariya, MS
CONTACT
2059347173
nvekariya@uabmc.edu

Principal Investigator

Pankaj Arora, MD, FAHA
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Pankaj Arora, MD, FAHA, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2030-07-31

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2030-07-31

Terms related to this study

Keywords Provided by Researchers

  • Systolic Blood Pressure
  • Polygenic Risk Score
  • Genomic Counseling
  • Health Belief Model
  • Cardiovascular Health

Additional Relevant MeSH Terms

  • Hypertension
  • Atherosclerotic Cardiovascular Disease