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Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage (REDUCE) (REDUCE)

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ClinicalTrials.gov Identifier: NCT04760717
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : November 23, 2022
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE February 16, 2021
First Posted Date  ICMJE February 18, 2021
Last Update Posted Date November 23, 2022
Actual Study Start Date  ICMJE March 19, 2021
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
Average change in home systolic blood pressure at 3 months [ Time Frame: Baseline, 3 month ]
The average home systolic blood pressure will be measured using a home blood pressure cuff
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
  • Proportion of patients achieving BP < 130/80 mm Hg [ Time Frame: 3 months ]
    The proportion of patients achieving BP < 130/80 mm Hg at 3 months will be measured
  • Number of antihypertensive medications at 3 months [ Time Frame: 3 months ]
    The number of antihypertensive medications at 3 months will be collected
  • Number of antihypertensive medications at 1 year [ Time Frame: 1 year ]
    The number of antihypertensive medications at 1 year will be collected
  • Stroke, myocardial infarction, or death [ Time Frame: 1 year ]
    Incidence of stroke of any type (ischemic or hemorrhagic), myocardial infarction, or death from any cause
  • Change in modified Rankin Scale score [ Time Frame: Baseline, 1 year ]
    Measure of neurologic disability (0=no disability to 6=dead)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage (REDUCE)
Official Title  ICMJE Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage (REDUCE)
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Intracerebral Hemorrhage
  • Spironolactone
Intervention  ICMJE Drug: Spironolactone Pill
Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.
Study Arms  ICMJE
  • Experimental: Spironolactone
    Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.
    Intervention: Drug: Spironolactone Pill
  • No Intervention: Standard Care
    Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2021)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04760717
Other Study ID Numbers  ICMJE 2000029811
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party Yale University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yale University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE American Heart Association
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP