RECRUITING

Regulating Blood Pressure During Recovery from Intracerebral Hemorrhage and Ischemic Stroke

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Conditions

Intracerebral HemorrhageIschemic StrokeSpironolactone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Regulating Blood Pressure During Recovery from Intracerebral Hemorrhage and Ischemic Stroke

Quick Facts

Study Start:2021-03-19
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04760717

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years
  2. 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. 3. Written, informed consent by patient or surrogate
  4. 4. Ability to comply with all study procedures and available for the duration of the study
  1. 1. Secondary ICH due to trauma, vascular malformation, or tumor
  2. 2. Life expectancy \< 1 year
  3. 3. eGFR \<45
  4. 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. 5. Known hypersensitivity to spironolactone
  6. 6. Upper arm greater than 17 inches in circumference
  7. 7. Pregnancy, planned pregnancy, or breastfeeding
  8. 8. Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria)
  9. 9. Systolic BP \>200 mmHg or diastolic BP \>110 mmHg at the time of randomization
  10. 10. Systolic BP \<120 mmHg at the time of randomization
  11. 11. Any condition which, in the judgement of the investigator, increases the risk to the patient
  12. 12. History of Addison's disease

Contacts and Locations

Study Locations (Sites)

Yale New Haven Hospital
New Haven, Connecticut, 06512
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-19
Study Completion Date2025-03

Study Record Updates

Study Start Date2021-03-19
Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

  • Intracerebral Hemorrhage
  • Ischemic Stroke
  • Spironolactone