Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

Launched by YALE UNIVERSITY · Feb 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called spironolactone can help lower blood pressure more effectively in stroke survivors compared to standard blood pressure treatments that do not include spironolactone. The trial specifically focuses on patients who have experienced either an intracerebral hemorrhage (a type of bleeding in the brain) or an ischemic stroke (caused by a blockage in a blood vessel in the brain).

To participate in this study, individuals must be at least 18 years old and have had a stroke confirmed by imaging tests. Participants will need to provide consent and agree to follow the study procedures. Throughout the trial, which is currently recruiting participants, those who qualify will be monitored to see how well the medication works in managing their blood pressure during recovery. It's important to note that certain conditions, such as severe kidney issues or pregnancy, may prevent someone from being eligible for this study. If you or a loved one fits the criteria and are interested, this trial might offer an opportunity to contribute to important research in stroke recovery.

Gender

ALL

Eligibility 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