Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

Phase 2

Recruiting

• Conditions: Intracerebral Hemorrhage; Ischemic Stroke; Spironolactone

• Registration Number: NCT04760717
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-18
• Study Start: 2021-03-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)