New Haven, Connecticut 06512

  • Spironolactone

Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

2000029811


NCT ID:

NCT04760717


Secondary ID:


Study Acronym:

REDUCE


Brief Title:

Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage (REDUCE)


Official Title:

Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage (REDUCE)


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Yale University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Study Dates

Start Date:March 19, 2021
Completion Date:March 2025
Completion Type:Anticipated
Primary Completion Date:March 2025
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 19, 2021
First Received Date:February 16, 2021

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in modified Rankin Scale score
Time Frame:Baseline, 1 year
Safety Issues:False
Description:Measure of neurologic disability (0=no disability to 6=dead)
Outcome Type:Secondary Outcome
Measure:Stroke, myocardial infarction, or death
Time Frame:1 year
Safety Issues:False
Description:Incidence of stroke of any type (ischemic or hemorrhagic), myocardial infarction, or death from any cause
Outcome Type:Secondary Outcome
Measure:Number of antihypertensive medications at 1 year
Time Frame:1 year
Safety Issues:False
Description:The number of antihypertensive medications at 1 year will be collected
Outcome Type:Secondary Outcome
Measure:Number of antihypertensive medications at 3 months
Time Frame:3 months
Safety Issues:False
Description:The number of antihypertensive medications at 3 months will be collected
Outcome Type:Secondary Outcome
Measure:Proportion of patients achieving BP < 130/80 mm Hg
Time Frame:3 months
Safety Issues:False
Description:The proportion of patients achieving BP < 130/80 mm Hg at 3 months will be measured
Outcome Type:Primary Outcome
Measure:Average change in home systolic blood pressure at 3 months
Time Frame:Baseline, 3 month
Safety Issues:False
Description:The average home systolic blood pressure will be measured using a home blood pressure cuff

Study Interventions

Intervention Type:Drug
Name:Spironolactone Pill
Description:Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.
Arm Name:Spironolactone

Study Arms

Study Arm Type:No Intervention
Arm Name:Standard Care
Description:Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment.
Study Arm Type:Experimental
Arm Name:Spironolactone
Description:Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Yale University
Agency Class:Other
Agency Type:Collaborator
Agency Name:American Heart Association

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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