Blood pressure treatment for stroke recovery
Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke
This study is testing if a blood pressure medication called spironolactone helps stroke survivors recover better than standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 5 sites (New Haven, Connecticut and 4 other locations) |
| Trial ID | NCT04760717 on ClinicalTrials.gov |
What this trial studies
This research aims to compare the effectiveness of blood pressure treatment regimens that include spironolactone against standard regimens in stroke survivors. The study will randomly assign 200 patients, ensuring a balance of white and non-white participants, to receive either spironolactone or standard antihypertensive treatment for one year. Participants will undergo baseline testing and will be monitored for home blood pressure readings over the course of the study, with the primary outcome being measured at three months. The trial is designed to provide insights into optimal blood pressure management in patients recovering from intracerebral hemorrhage or ischemic stroke.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced a symptomatic intracerebral hemorrhage or ischemic stroke.
Not a fit: Patients with secondary intracerebral hemorrhage, severe renal impairment, or contraindications to spironolactone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood pressure management strategies for stroke survivors, potentially enhancing their recovery and quality of life.
How similar studies have performed: Other studies have explored blood pressure management in stroke patients, but this specific approach using spironolactone is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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
Where this trial is running
New Haven, Connecticut and 4 other locations
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Wake Forest Baptist Health — Winston-Salem, North Carolina, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Temple University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.