The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering blood pressure in stroke survivors.
This is a pragmatic, randomized, open-label, blinded-endpoint trial comparing spironolactone-containing antihypertensive regimens versus standard antihypertensive regimens based on the 2017 AHA/ACC guidelines in stroke survivors. This study will randomize a total of 200 patients, 100 white and 100 non-white patients, at least three weeks after last known normal or symptom discovery/onset of their stroke to an antihypertensive regimen with spironolactone once daily or standard BP control based on the 2017 AHA/ACC guidelines for 1 year. Participants will undergo baseline testing for neurohormonal levels and will be followed for 12 months with regular assessment of home BP readings. The primary outcome of home systolic BP will be measured at 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.
Yale New Haven Hospital
New Haven, Connecticut, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Average change in home systolic blood pressure at 3 months
The average home systolic blood pressure will be measured using a home blood pressure cuff
Time frame: Baseline, 3 month
Proportion of patients achieving BP < 130/80 mm Hg
The proportion of patients achieving BP \< 130/80 mm Hg at 3 months will be measured
Time frame: 3 months
Number of antihypertensive medications at 3 months
The number of antihypertensive medications at 3 months will be collected
Time frame: 3 months
Number of antihypertensive medications at 1 year
The number of antihypertensive medications at 1 year will be collected
Time frame: 1 year
Stroke, myocardial infarction, or death
Incidence of stroke of any type (ischemic or hemorrhagic), myocardial infarction, or death from any cause
Time frame: 1 year
Change in modified Rankin Scale score
Measure of neurologic disability (0=no disability to 6=dead)
Time frame: Baseline, 1 year
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University of Texas Health Science Center at Houston
Houston, Texas, United States