Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

Last updated: April 8, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

2

Condition

Stroke

Brain Injury

Blood Clots

Treatment

Spironolactone Pill

Clinical Study ID

NCT04760717
2000029811
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Symptomatic ICH confirmed by head CT or brain MRI during hospitalization OR ischemicstroke patients. Ischemic stroke will be defined by focal signs/symptoms of anyduration associated with evidence of acute arterial infarction on neuroimaging orclinical evidence of cerebral focal arterial ischemic injury with symptomspersisting ≥ 24 hours.

  3. Written, informed consent by patient or surrogate

  4. Ability to comply with all study procedures and available for the duration of thestudy

Exclusion

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 thetwo 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 3-12months 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 thepatient

  12. History of Addison's disease

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Spironolactone Pill
Phase: 2
Study Start date:
March 19, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Yale New Haven Hospital

    New Haven, Connecticut 06512
    United States

    Active - Recruiting

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.