Arterial Stiffness and Blood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
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
Trial design
Design model
Parallel
Treatments tested in this trial
Blood pressure treatment algorithm
Other interventionSingle 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.
Treatment groups
228 Participants
are divided into 2 treatment groupsGroup A: Intensive BP targetsExperimental treatment 1 intervention
Group B: Standard blood pressure targetsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months2
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.
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
12 months2
Brachial blood pressure
Upper arm brachial blood blood pressure measurements (mmHg).
Time frame
12 monthsOther outcomes
1
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
Time frame
12 months2
Safety outcome - Electrolyte abnormalities
Serum sodium \<133 or \>150 mEq/L, serum potassium \<3.0 or \>5.5 mEq/L
Time frame
12 months3
Safety outcome - Hypotension
Low blood pressure (\<90 mmHg systolic) resulting symptoms AND an ER visit or hospitalization.
Time frame
12 months4
Safety outcome - Falls
Any fall resulting in an ER visit or hospitalization.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
VA Tennessee Valley Health Care System
Collaborator
Birmingham, Alabama VA Medical Center
Collaborator
The Lundquist Institute
Collaborator
University of Wisconsin, Madison
Collaborator
Source ClinicalTrials.gov