Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage (REDUCE)

• Sponsor: Yale University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04760717
• Collaborator: American Heart Association (Other)
• Enrollment: 200
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 47.4
• Patients Per Site: 50
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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 brain hemorrhage survivors

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage; Spironolactone	Drug: Spironolactone Pill	Phase 2

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 intracerebral hemorrhage (ICH) survivors.

This study will randomize a total of 200 patients, 100 of each white and non-white patients, between 3 weeks to 6 months after ICH 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage (REDUCE)
• Actual Study Start Date: Mar 19, 2021
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spironolactone Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.	Drug: Spironolactone Pill; Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.
No Intervention: Standard Care Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Number of antihypertensive medications at 3 months [3 months]

   The number of antihypertensive medications at 3 months will be collected

3. Number of antihypertensive medications at 1 year [1 year]

   The number of antihypertensive medications at 1 year will be collected

4. Stroke, myocardial infarction, or death [1 year]

   Incidence of stroke of any type (ischemic or hemorrhagic), myocardial infarction, or death from any cause

5. Change in modified Rankin Scale score [Baseline, 1 year]

   Measure of neurologic disability (0=no disability to 6=dead)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Hospital	New Haven	Connecticut	United States	06512
2	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
3	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
4	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Yale University
• American Heart Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04760717
• Other Study ID Numbers: 2000029811
• First Posted: Feb 18, 2021
• Last Update Posted: Dec 10, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cerebral Hemorrhage; Hemorrhage; Spironolactone

Study Results

No Results Posted as of Dec 10, 2021