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

Madeleine Puissant

Status and phase: Enrolling; Phase 4

Conditions: Non-Traumatic Subarachnoid Hemorrhage

Treatments: Drug: Metoprolol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06569212

2146714

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

Metoprolol (Beta-adrenergic blockade)

Experimental group

Description:

Patients will receive metoprolol during the first 72-hours of hospitalization after non-traumatic SAH.

Treatment:

Drug: Metoprolol

Placebo

Placebo Comparator group

Description:

Patients will receive placebo during the first 72-hours of hospitalization after non-traumatic SAH.

Treatment:

Drug: Placebo