Testing genetic blood pressure risk results with counseling in young adults
Tests a genetic blood pressure risk score with counseling in adults with high blood pressure.
Plain-language title generated from the registry record
Registry title: Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure
Key facts
- Where
- Birmingham, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT06962488, who can take part
Where in United States
- University of Alabama at BirminghamBirmingham, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Alabama at Birmingham
- Trial code
- NCT06962488
- Record updated
- 9 October 2026
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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: Use of more than two antihypertensive medication classes; History of cardiovascular disease, including Myocardial infarction, Angina, Cardiac arrhythmia, Coronary heart disease, Heart failure, Stroke, or transient ischemic attack; Significant psychiatric illness (assessed via Global Health Questionnaire-12); 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; Body mass index (BMI) <18.5 kg/m² or >45 kg/m²; Baseline office SBP >160 mm Hg or DBP >100 mm Hg; Not hypertensive based on 24-hour ABPM (per 2017 ACC/AHA criteria); Pregnant or breastfeeding; Moderate or severe anxiety (Beck Anxiety Inventory [BAI] score >16).