NCT06569212PHASE4Recruiting
Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)
Madeleine Puissant
Start Date
9/23/2024
Completion Date
9/1/2029
Summary
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).
Detailed Description
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH) on the brain and cardiac tissue damage and inflammation, we will conduct a pilot randomized controlled trial comparing (1) sympathetic nervous system (SNS) activation, (2) cardiac rhythm abnormalities, (3) biomarkers of brain and cardiac tissue damage, and (4) and neutrophil activity in patients receiving metoprolol (n=10) or placebo (n=10) for the first 72-hours after SAH.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* \>18 years of age
* Neuro-imaging confirmed non-traumatic subarachnoid hemorrhage
Exclusion Criteria:
* Traumatic cause of subarachnoid hemorrhage (e.g. fall, motor vehicle accident, other blunt trauma) as this is a different mechanism of hemorrhage.
* Other forms of traumatic or non-traumatic intracranial bleed including intracerebral hemorrhage (ICH), subdural hemorrhage, epidural hemorrhage
* Pregnancy (as the study medication, metoprolol, has FDA Pregnancy Category C rating)
* Unstable vital signs not amenable to beta-1 adrenergic receptor inhibitor (B1ARi) administration including:
* Systolic blood pressure \< 80 mmHg not stabilized on vasopressor medications
* Heart rate \< 50 bpm associated with hypotension
* Patients requiring vasopressor agents due to hypotension (SBP \<80 mmHg)
* Other vital sign exclusion at the discretion of the treatment team
* Previous history of severe heart failure (Stage C or D Heart Failure and/or NYHA Class III or IV)
* Patient or legally authorized representative unwilling to provide informed consent
Interventions
DRUG
Metoprolol
DRUG
Placebo
Conditions
Non-Traumatic Subarachnoid Hemorrhage
Locations
MaineHealth
Portland, Maine 04012
United States