Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke (REDUCE)

Yale University

Status and phase: Enrolling; Phase 2

Conditions: Ischemic Stroke; Spironolactone; Intracerebral Hemorrhage

Treatments: Drug: Spironolactone Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT04760717

2000029811

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Spironolactone

Experimental group

Description:

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

Treatment:

Drug: Spironolactone Pill

Standard Care

No Intervention group

Description:

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