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Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure

Clinical Implementation of Blood Pressure Polygenic Risk Score

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed for 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether sharing a genetic risk score for blood pressure, along with counseling, helps people lower blood pressure and build healthier habits. It is for adults ages 18–55 with high blood pressure and poor heart health. Participants will get either usual care or genetic risk results with counseling and will be followed for 12 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–55 at screening.
  • Have high blood pressure: a resting office reading with a top number of 130–160 or a bottom number of 80–100 mm Hg, or take blood pressure medicine.
  • Have poor heart health, shown by a Life’s Essential 8 score below 50.
  • Willing and able to wear a blood pressure monitor for 24 hours to confirm high blood pressure.
  • Able to understand the study and agree to take part.

Who can't join

  • History of heart or blood vessel disease, including heart attack, angina (heart-related chest pain), abnormal heartbeat, heart artery disease, heart failure, stroke, or mini-stroke.
  • Body mass index (BMI), a measure of weight compared with height, below 18.5 or above 45.
  • Starting office blood pressure with a top number above 160 or a bottom number above 100 mm Hg, or taking more than two types of blood pressure medicine.
  • The 24-hour blood pressure test does not confirm high blood pressure.
  • Pregnant or breastfeeding.
  • Kidney filtering test result (eGFR) below 60, or a urine protein test (albumin-to-creatinine ratio) of 30 mg/g or higher.
  • Liver enzyme blood test results more than three times the highest normal level.
  • A serious mental health condition based on the Global Health Questionnaire-12, or moderate or severe anxiety with a Beck Anxiety Inventory score above 16.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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).

Study sites (1)

AL