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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2029-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Non-Traumatic Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metoprolol (Beta-adrenergic blockade)

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

Group Type EXPERIMENTAL

Metoprolol

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Metoprolol succinate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No