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RECRUITING

NCT06495710

Arterial Stiffness and Blood Pressure

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

Hypertension is a common and treatable disorder that remains the leading preventable cause of heart disease. Blood pressure treatment relies mainly on upper arm blood pressure readings and ignores blood vessel physiology and underlying individual genetic information. Older Veterans with hypertension are less likely to be treated to goal blood pressure because there are conflicting recommendations for what constitutes "optimal" in older adults. The investigators have developed a novel way to non-invasively assess the components of blood vessel stiffness that is related to blood pressure (load-dependent stiffness). This project will generate new knowledge about how different blood pressure treatment goals (intensive vs standard) impact different components of arterial stiffness and if these differences can be explained through genetic analysis. Results from this project will offer the VA an updated blueprint for personalizing blood pressure care in older adults, ultimately improving cardiovascular health.

Official title: Load-Dependent Arterial Stiffness to Optimize Blood Pressure Management in Older Veterans (LOADED BP)

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2025-05-01

Completion Date

2028-12-31

Last Updated

2025-05-08

Healthy Volunteers

Conditions

Hypertension Vascular Stiffness Aging

Interventions

OTHER

Blood pressure treatment algorithm

Single or combination antihypertensive therapy as needed: 1) amlodipine (2.5-10 mg), 2) telmisartan (20-80 mg) or losartan (25-100 mg), 3) chlorthalidone (6.25-25 mg), or 4) spironolactone (12.5-50 mg). a two-drug regimen with either amlodipine + chlorthalidone or telmisartan + chlorthalidone will be initiated following randomization. If a diuretic is contraindicated, amlodipine + telmisartan will be initiated. For those over 75 years, either amlodipine or telmisartan will be initiated at baseline if SBP is \<140 mmHg. In the standard treatment group (SBP goal of \< 140 mmHg), participants will either be prescribed amlodipine or telmisartan/losartan as initial therapy. If \>3 medications are necessary to reach the intensive goal and no first line options remain, potassium sparing diuretics or direct vasodilators will be considered.

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

Locations (3)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States