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Search / Trial NCT06962488

Clinical Implementation of Blood Pressure Polygenic Risk Score

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Apr 29, 2025

Trial Information

Current as of July 21, 2025

Not yet recruiting

Keywords

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

ClinConnect Summary

This clinical trial is studying how a special genetic test, called a polygenic risk score (PRS), can help people with high blood pressure (hypertension) improve their health. The trial will look at whether sharing this genetic information with young and middle-aged adults can motivate them to make healthier lifestyle choices, like eating better and exercising more, which could help lower their blood pressure and reduce the risk of heart problems in the future. Researchers will enroll 300 adults aged 18 to 55 who have high blood pressure and poor cardiovascular health. Participants will either receive regular medical care or will be given their genetic results along with counseling to help them understand their risk and how to improve their health.

To join the study, participants need to be between 18 and 55 years old, have a diagnosis of high blood pressure, and have a low cardiovascular health score. They should also be willing to wear a device that monitors their blood pressure for 24 hours. However, people with certain health issues, such as a history of heart disease or specific kidney problems, won't be eligible. The study will last for one year, and researchers will track changes in participants' blood pressure and health behaviors over time. This trial is important because it aims to use genetic information to better manage high blood pressure and prevent heart disease.

Gender

ALL

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).

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Birmingham, Alabama, United States

Patients applied

0 patients applied

Trial Officials

Pankaj Arora, MD, FAHA

Principal Investigator

University of Alabama at Birmingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported