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

Phase 4

Recruiting

• Conditions: Non-Traumatic Subarachnoid Hemorrhage
• Interventions: Drug: Metoprolol; Drug: Placebo

• Registration Number: NCT06569212
• Lead Sponsor: Madeleine Puissant

Brief 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.

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-23
• Study Start: 2024-09-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2026-09
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoprolol (Beta-adrenergic blockade)	Metoprolol	Patients will receive metoprolol during the first 72-hours of hospitalization after non-traumatic SAH.
Placebo	Placebo	Patients will receive placebo during the first 72-hours of hospitalization after non-traumatic SAH.

Primary Outcome Measures

Name	Time	Method
Delta neutrophil activity	7 days	Delta neutrophil activity between intervention and control groups.
Delta QTc length	7 days	Change (Delta) QTc length between intervention and control groups.

Secondary Outcome Measures

Name	Time	Method
Adverse events	7-days	Including but not limited to symptomatic bradycardia, symptomatic hypotension, or complete heart block
Number of patients with evidence of cardiac injury	7-days	Measurement of troponin levels, echocardiograph
Need for Vasopressors	7-days	Any documented intravenous vasoactive medication administration
Sympathetic Nervous System (SNS) Activity	7-days	Catecholamine Measurements
ICU Length of Stay (LOS)	Up to 15-weeks	Number of full days
In-hospital mortality	Up to 15-weeks	Whether patient died during during sentinel hospitalization
Neutrophil Activity	7 days	Measurement of neutrophils in CSF and serum samples
Evidence of Clinical Vasospasm	Up to 15-weeks	Evidence of clinical vasospasm
Hospital Length of Stay (LOS)	Up to 15-weeks	Number of full days

Trial Locations

Locations (1)

MaineHealth; 🇺🇸 Portland, Maine, United States