Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage (REDUCE)

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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 brain hemorrhage survivors

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: American Heart Association
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Symptomatic ICH confirmed by head CT or brain MRI during hospitalization

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