Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intracerebral Hemorrhage Ischemic Stroke Spironolactone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Spironolactone

Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.

Group Type EXPERIMENTAL

Spironolactone Pill

Intervention Type DRUG

Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.

Standard Care

Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spironolactone Pill

Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No