Arterial Stiffness and Blood Pressure
NCT Number: NCT06495710
Acronym: LOADED-BP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension|Vascular Stiffness|Aging
Interventions: OTHER: Blood pressure treatment algorithm
Sponsor: VA Office of Research and Development
Collaborators: Nashville VA Medical Center|Birmingham, Alabama VA Medical Center|The Lundquist Institute|University of Wisconsin, Madison
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 228
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-09-29
Locations: Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama, 35233-1927, United States|Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville, Tennessee, 37212-2637, United States|William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison, Wisconsin, 53705-2254, United States

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.

Primary Outcome Measures: Load-dependent arterial stiffness measured with pulse wave velocity (m/s), Load dependent stiffening is measured with ultrasound and tonometry and is the stiffness component due to elevated blood pressure increasing collagen fiber loading without an intrinsic change to the artery wall. The primary outcomes of load-dependent stiffness will be assessed at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy., 12 months|Structural arterial stiffness measured with pulse wave velocity (m/s), Structural stiffening is measured with ultrasound and tonometry and is the stiffness component due to growth (eg. intima-media thickening) and remodeling (eg. elastin fragmentation, collagen accumulation) of the arterial wall. The primary outcomes of structural arterial stiffness will be assessed at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy., 12 months
Secondary Outcome Measures: Total arterial stiffness measured with pulse wave velocity (m/s), Local total arterial stiffness measured by tonometry and regional arterial stiffness measured by tonometry. This will be measured at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy., 12 months|Brachial blood pressure, Upper arm brachial blood blood pressure measurements (mmHg)., 12 months
Other Outcome Measures: Safety outcome - Acute Kidney Injury, Rise in serum creatinine by at least 50% to a value of \>1.5 mg/dL since the last study lab, 12 months|Safety outcome - Electrolyte abnormalities, Serum sodium \<133 or \>150 mEq/L, serum potassium \<3.0 or \>5.5 mEq/L, 12 months|Safety outcome - Hypotension, Low blood pressure (\<90 mmHg systolic) resulting symptoms AND an ER visit or hospitalization., 12 months|Safety outcome - Falls, Any fall resulting in an ER visit or hospitalization., 12 months