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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone | Experimental | Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment. |
|
| Standard Care | No Intervention | Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone Pill | Drug | Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Number of antihypertensive medications at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Sheth, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06512 | United States | ||
| Wake Forest Baptist Health |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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The number of antihypertensive medications at 3 months will be collected
| 3 months |
| Number of antihypertensive medications at 1 year | The number of antihypertensive medications at 1 year will be collected | 1 year |
| Stroke, myocardial infarction, or death | Incidence of stroke of any type (ischemic or hemorrhagic), myocardial infarction, or death from any cause | 1 year |
| Change in modified Rankin Scale score | Measure of neurologic disability (0=no disability to 6=dead) | Baseline, 1 year |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |