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

NCT06569212 | Recruiting Phase 4 DMC

• 1 other identifier: 2146714
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Traumatic Subarachnoid Hemorrhage

Keywords

Beta-adrenergic blockade; Cardiac dysfunction; Inflammation

Outcome Measures

Primary Outcomes (2)

• Delta QTc length

  Change (Delta) QTc length between intervention and control groups.

  7 days

• Delta neutrophil activity

  Delta neutrophil activity between intervention and control groups.

  7 days

Secondary Outcomes (9)

• Adverse events

  7-days

• Number of patients with evidence of cardiac injury

  7-days

• Need for Vasopressors

  7-days

• Sympathetic Nervous System (SNS) Activity

  7-days

• Neutrophil Activity

  7 days

Study Arms (2)

Metoprolol (Beta-adrenergic blockade)

EXPERIMENTAL

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

Drug: Metoprolol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Metoprolol 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

Also known as: Metoprolol succinate

Metoprolol (Beta-adrenergic blockade)

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Neuro-imaging confirmed non-traumatic subarachnoid hemorrhage

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Madeleine Puissant: lead
• MaineHealth: collaborator

Study Sites (1)

MaineHealth

Portland, Maine, 04012, United States

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Madeleine Puissant, MD, PhD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine Puissant, MD, PhD

CONTACT

2076613660; Madeleine.Puissant@mainehealth.org

Christine Lord

CONTACT

Christine.Lord@mainehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 23, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At study completion and until 6-months post-publication.
• Access Criteria: A de-identified data set will be made available and people may request access to this.

Locations

US (1)