Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)

Purpose

To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).

Condition

  • Non-Traumatic Subarachnoid Hemorrhage

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Metoprolol (Beta-adrenergic blockade) 		Patients will receive metoprolol during the first 72-hours of hospitalization after non-traumatic SAH.
  • Drug: Metoprolol
    Metoprolol Dosing: Metoprolol Injection (instructions: 5mg, once) Metoprolol Tab (25mg PO, q12 hours, timed to start 1hr after Metoprolol Injection, 6 doses) If unable to take PO medication, Metoprolol Injection (instructions, 5mg q6hrs for 12 doses) Continue for 72-hours of administration unless reaching stopping criteria
    Other names:
    • Metoprolol succinate
Placebo Comparator
Placebo 		Patients will receive placebo during the first 72-hours of hospitalization after non-traumatic SAH.
  • Drug: Placebo
    Placebo Dosing: Placebo Injection (instructions: 5mL NS, once) Placebo Tab (1 tab PO, q12 hours, timed to start 1hr after placebo injection, 6 doses) If unable to take PO medication, Placebo Injection (instructions, 5mL q6hrs for 12 doses) Continue for 72-hours of administration unless reaching stopping criteria

Recruiting Locations

MaineHealth
Portland, Maine 04012
Contact:
Christine Lord
2076613660
christine.lord@mainehealth.org

More Details

Status
Recruiting
Sponsor
Madeleine Puissant

Study Contact

Madeleine Puissant, MD, PhD
2076613660
Madeleine.Puissant@mainehealth.org

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.