Status:
RECRUITING
Arterial Stiffness and Blood Pressure
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
VA Tennessee Valley Health Care System
Birmingham, Alabama VA Medical Center
Conditions:
Hypertension
Vascular Stiffness
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 blo...
Detailed Description
Aims and Rationale: Hypertension is ubiquitous within the VA system and is the leading cause of preventable cardiovascular disease in the United States. Over 1/3 of Veterans with hypertension are not ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT06495710
Start Date
May 1 2025
End Date
December 31 2028
Last Update
May 8 2025
Active Locations (3)
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1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233-1927
2
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
3
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705-2254