Assessing blood pressure treatment effects on arterial stiffness in older veterans
Load-Dependent Arterial Stiffness to Optimize Blood Pressure Management in Older Veterans (LOADED BP)
This study is testing whether different blood pressure treatment goals can help reduce arterial stiffness in older veterans with high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 3 sites (Birmingham, Alabama and 2 other locations) |
| Trial ID | NCT06495710 on ClinicalTrials.gov |
What this trial studies
This study investigates how different blood pressure treatment goals affect arterial stiffness in older veterans with hypertension. It utilizes non-invasive methods to measure arterial stiffness and incorporates genetic analysis to personalize treatment approaches. Participants will be randomized to receive either intensive or standard blood pressure treatment, and their responses will be monitored through various assessments. The goal is to bridge the gap in hypertension management by providing tailored care based on individual physiological and genetic factors.
Who should consider this trial
Good fit: Ideal candidates are veterans over 60 years old with a diagnosis of hypertension or those taking antihypertensive medications.
Not a fit: Patients with specific contraindications for blood pressure medications or those with a recent cardiovascular event may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized blood pressure management strategies for older adults, reducing the risk of cardiovascular disease.
How similar studies have performed: Other studies have shown promise in using personalized approaches to hypertension management, but this specific methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 2 other locations
- Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States (Not_yet_recruiting)
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States (Enrolling_by_invitation)
- William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Adam Gepner — William S. Middleton Memorial Veterans Hospital, Madison, WI
- Study coordinator: Adam Gepner
- Email: adam.gepner@va.gov
- Phone: (608) 256-1901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.