Actively Recruiting
Load-Dependent Arterial Stiffness to Optimize Blood Pressure Management in Older Veterans (LOADED BP)
Led by VA Office of Research and Development · Updated on 2026-04-13
228
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
V
VA Tennessee Valley Health Care System
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve blood pressure treatment in older Veterans with hypertension by studying how different blood pressure goals affect arterial stiffness and exploring genetic factors. Hypertension is a common and treatable condition but remains a leading cause of heart disease. The study addresses the conflicting recommendations for blood pressure targets in older adults and focuses on better understanding individual differences in treatment response using novel non-invasive arterial stiffness measures and genetic analysis. Participants will be randomly assigned to receive either intensive blood pressure treatment targeting less than 120 mmHg systolic or standard treatment targeting less than 140 mmHg systolic. Treatment involves antihypertensive medications such as amlodipine, telmisartan, losartan, chlorthalidone, or spironolactone, adjusted according to the study protocol over 12 months. Arterial stiffness will be measured at baseline and at 3, 6, and 12 months using pulse wave velocity and ultrasound, with medications prescribed and adjusted at each visit. Throughout the 12-month study, participants will undergo regular evaluations including blood pressure monitoring, arterial stiffness assessments, carotid artery ultrasound, and genetic testing. Researchers will track medication adherence and serious side effects like hypotension or kidney injury. The main outcomes are changes in load-dependent and structural arterial stiffness, with additional measures including total arterial stiffness and brachial blood pressure. This trial seeks to personalize blood pressure care and improve cardiovascular health in older Veterans.
CONDITIONS
Brief Title
Arterial Stiffness and Blood Pressure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female Veterans aged 60 years or older
- Diagnosis of hypertension or currently taking up to 4 antihypertensive medications
- Documented systolic blood pressure readings of 140 mmHg or higher on 2 or more office visits, or average home blood pressure readings of 135 mmHg or higher
- Willingness to be randomized to intensive (<120 mmHg) or standard (<140 mmHg) blood pressure treatment and have medications adjusted per study protocol
- Willingness to undergo arterial stiffness testing and carotid artery ultrasound
You will not qualify if you...
- Need for specific blood pressure medication not included in the study or known secondary cause of hypertension
- Standing systolic blood pressure below 110 mmHg
- History of recent cardiovascular events within the past 12 months, including coronary artery disease, heart failure hospitalization, atrial fibrillation, or peripheral arterial disease intervention
- Class I indication for beta-blocker use including atrial arrhythmias
- Left ventricular systolic function below 50% or moderate to severe aortic stenosis
- History of stroke
- Chronic kidney disease with eGFR below 30 mL/min/m2, proteinuria over 1 gram/day, or polycystic kidney disease
- Active cancer except untreated, non-metastatic prostate cancer or non-melanoma skin cancer
- Hypoxemic pulmonary disease
- Active rheumatologic or connective tissue diseases
- Human immunodeficiency virus
- Illness with infection or fever over 38°C
- Hospitalization within past 4 weeks
- Arm circumference too large or small for accurate blood pressure measurements
- Factors limiting study adherence such as active substance abuse, plans to move out of study area within 12 months, or history of poor medication adherence or missed clinic visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive guideline-based antihypertensive therapy with medications adjusted to achieve either intensive (<120 mmHg) or standard (<140 mmHg) blood pressure targets. Arterial stiffness and blood pressure are assessed at baseline and during treatment to monitor response.
Visits at baseline, 3, 6, and 12 months with medication adjustments at each visit
Trial Site Locations
Total: 3 locations
1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233-1927
Not Yet Recruiting
2
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
Enrolling by Invitation
3
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705-2254
Actively Recruiting
Research Team
A
Adam Gepner
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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