Regulating Blood Pressure During Recovery from Intracerebral Hemorrhage and Ischemic Stroke

Description

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.

Conditions

Intracerebral Hemorrhage, Ischemic Stroke, Spironolactone

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Study Overview

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Study Details

Study overview

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.

Regulating Blood Pressure During Recovery from Intracerebral Hemorrhage and Ischemic Stroke

Regulating Blood Pressure During Recovery from Intracerebral Hemorrhage and Ischemic Stroke

Condition
Intracerebral Hemorrhage
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06512

Winston-Salem

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States, 27157

Philadelphia

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Temple University Hospital, Philadelphia, Pennsylvania, United States, 19140

Houston

University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Study Record Dates

2025-03