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Search / Trial NCT06495710

Arterial Stiffness and Blood Pressure

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jul 10, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Hypertension Vascular Stiffness Aging

ClinConnect Summary

This clinical trial is studying how different blood pressure treatment goals affect older Veterans with high blood pressure, also known as hypertension. The researchers want to understand how the stiffness of blood vessels, which can change as we age, relates to blood pressure and whether these changes can be influenced by genetics. By comparing two treatment approaches—one more intensive and one standard—the goal is to find better ways to manage blood pressure in older adults and ultimately improve their heart health.

To participate, you need to be over 60 years old and have high blood pressure or be taking medication for it. You’ll need to have your blood pressure checked during visits to your doctor, and you should be open to switching your blood pressure medications as part of the study. Participants will also undergo some tests to measure blood vessel stiffness and check the health of the carotid artery, which is important for understanding overall cardiovascular health. If you have certain medical conditions or factors that might interfere with participation, you may not be eligible. This study aims to personalize blood pressure care for older Veterans, helping to make treatments more effective for each individual.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male and female participants from VA VISN 7, 9, and 12 will be eligible to participate if they are over age 60 years and have a diagnosis of hypertension or take antihypertensive medications (up to 4).
  • Veterans will require documented SBP readings on 2 or more office visits that are 140 mmHg or average home blood pressure readings 135 mmHg to be eligible for the trial.
  • Participants must be willing to be randomized to intensive or standard blood pressure treatment and have blood pressure medications adjusted per the study protocol.
  • They must be willing to undergo tonometric evaluation of arterial stiffness, and carotid artery ultrasound.
  • Exclusion Criteria:
  • Participants who have an indication for a specific BP lowering medication that is not included in the study protocol or a known secondary cause of hypertension will be excluded.
  • * Patients will be excluded if they have:
  • a standing SBP \<110 mmHg
  • past history of a recent CVD event in the past 12 months (i.e., coronary artery disease event/intervention, congestive heart failure exacerbation or heart failure hospitalization, atrial fibrillation, or peripheral arterial disease intervention)
  • a class I indication for betablocker use including atrial arrhythmias
  • left-ventricular systolic function \<50%, \>moderate aortic stenosis
  • history of stroke
  • chronic kidney disease (eGFR\<30 mL/min/m2) or proteinuria in excess of 1 gram/day or polycystic kidney disease
  • active cancer (other than untreated, non-metastatic prostate cancer and non-melanoma skin cancer)
  • hypoxemic pulmonary disease
  • active rheumatologic or connective tissue diseases (i.e., systemic lupus erythematosus, rheumatoid arthritis, etc.)
  • human immunodeficiency virus
  • illness with any infectious etiology or fever \>38°C (i.e., upper respiratory illness, gastrointestinal illness, etc.)
  • hospitalization for any reason within the prior 4 weeks
  • Participants will be excluded if arm circumference is too large/small to allow accurate blood pressure recordings
  • The investigators will also exclude those with factors that may limit adherence to the study interventions or follow-up including active substance abuse, plans to move outside the study catchment areas within 12 months or a history of poor medication adherence or clinic no-shows

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Nashville, Tennessee, United States

Madison, Wisconsin, United States

Birmingham, Alabama, United States

Patients applied

0 patients applied

Trial Officials

Adam Gepner

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported