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


NCT ID:

NCT04760717


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06512
United States

Kevin Sheth, MD
Phone: 203-737-8051
Email: kevin.sheth@yale.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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