Intracerebral Hemorrhage, Ischemic Stroke, Spironolactone
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSpironolactone Pill
Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.
Sponsors
Yale University
American Heart Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Symptomatic ICH confirmed by head CT or brain MRI during hospitalization OR ischemic stroke patients. Ischemic stroke will be defined by focal signs/symptoms of any duration associated with evidence of acute arterial infarction on neuroimaging or clinical evidence of cerebral focal arterial ischemic injury with symptoms persisting ≥ 24 hours. 3. Written, informed consent by patient or surrogate 4. Ability to comply with all study procedures and available for the duration of the study
Exclusion criteria
1. Secondary ICH due to trauma, vascular malformation, or tumor 2. Life expectancy \< 1 year 3. eGFR \<45 4. Serum potassium greater than or equal to the upper limit of normal of the lab on the two most recent consecutive potassium levels prior to enrollment 5. Known hypersensitivity to spironolactone 6. Upper arm greater than 17 inches in circumference 7. Pregnancy, planned pregnancy, or breastfeeding 8. Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria) 9. Systolic BP \>200 mmHg or diastolic BP \>110 mmHg at the time of randomization 10. Systolic BP \<120 mmHg at the time of randomization 11. Any condition which, in the judgement of the investigator, increases the risk to the patient 12. History of Addison's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average change in home systolic blood pressure at 3 months | Baseline, 3 month | The average home systolic blood pressure will be measured using a home blood pressure cuff |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving BP < 130/80 mm Hg | 3 months | The proportion of patients achieving BP \< 130/80 mm Hg at 3 months will be measured |
| Number of antihypertensive medications at 3 months | 3 months | The number of antihypertensive medications at 3 months will be collected |
| Number of antihypertensive medications at 1 year | 1 year | The number of antihypertensive medications at 1 year will be collected |
| Stroke, myocardial infarction, or death | 1 year | Incidence of stroke of any type (ischemic or hemorrhagic), myocardial infarction, or death from any cause |
| Change in modified Rankin Scale score | Baseline, 1 year | Measure of neurologic disability (0=no disability to 6=dead) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKevin Sheth, MD
Yale University
Outcome results
None listed