Arterial Stiffness and Blood Pressure

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
VA Office of Research and Development
Study ID
NCT06495710
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood pressure treatment algorithm — OTHER
    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.

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intensive BP targets
    \<120 mmHg systolic)
  • Active Comparator: Standard blood pressure targets
    \<140 mmHg systolic

Primary Outcome Measure

Load-dependent arterial stiffness measured with pulse wave velocity (m/s) [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Birmingham VA Medical Center, Birmingham, ALBirminghamAlabama35233-1927
Nicole Lohr, MD
205-934-9166
Tennessee Valley Healthcare System Nashville Campus, Nashville, TNNashvilleTennessee37212-2637-
William S. Middleton Memorial Veterans Hospital, Madison, WIMadisonWisconsin53705-2254
Adam Gepner
[email protected]
608-256-1901
Amy J Hein
[email protected]
(608) 280-7222
Adam Gepner (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Birmingham VA Medical Center, Birmingham, AL· Birmingham, ALTennessee Valley Healthcare System Nashville Campus, Nashville, TN· Nashville, TNWilliam S. Middleton Memorial Veterans Hospital, Madison, WI· Madison, WI

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