Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

Ischemic Stroke Clinical Trial

— REDUCE  

Official title:

Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04760717
• Other study ID #: 2000029811
• Status: Recruiting
• Phase: Phase 2
• Start date: March 19, 2021
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Infarction
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemia
• Ischemic Stroke
• Spironolactone
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

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