RecruitingNot ApplicableNCT06495710

Arterial Stiffness and Blood Pressure

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


Sponsor

VA Office of Research and Development

Enrollment

228 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether intensively lowering blood pressure in veterans over 60 with high blood pressure reduces arterial stiffness (a marker of heart disease risk), compared to standard blood pressure treatment. **You may be eligible if...** - You are a US veteran over 60 years old - You have a diagnosis of hypertension or take blood pressure medications - Your blood pressure readings have been 140 mmHg or higher in the office (or 135 mmHg at home on average) - You are willing to have your blood pressure medications adjusted based on study protocol **You may NOT be eligible if...** - Your blood pressure is already well controlled - You have conditions that make intensive blood pressure treatment unsafe - You are unable to participate in regular follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood 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.


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

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NCT06495710


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