No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 55
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
300 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 55 with high blood pressure and poor heart health. Participants will receive either standard care or information about their genetic risk for high blood pressure, along with support to make healthier choices over a year.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 55 years old.
I have been diagnosed with high blood pressure.
I have poor heart health.
I can undergo 24-hour blood pressure monitoring.
I can give my consent to participate.
You may not be able to join if
I have a history of heart disease.
My body mass index (BMI) is under 18.5 or over 45.
My blood pressure is too high at the start.
I use more than two types of blood pressure medications.
I am not high blood pressure based on 24-hour monitoring.
I am pregnant or breastfeeding.
My kidney function is low.
I have significant mental health issues.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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)…
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.
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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 us…
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).
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