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Recruiting NCT06569212

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

Phase IV Interventional Non-Traumatic Subarachnoid Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metoprolol, Placebo.
Who it may be relevant to
Registry conditions: Non-Traumatic Subarachnoid Hemorrhage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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
  • 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

Primary outcome measures

  • Delta QTc length [Time frame: 7 days]
  • Delta neutrophil activity [Time frame: 7 days]
Secondary outcome measures (9)
  • Adverse events [Time frame: 7-days]
  • Number of patients with evidence of cardiac injury [Time frame: 7-days]
  • Need for Vasopressors [Time frame: 7-days]
  • Sympathetic Nervous System (SNS) Activity [Time frame: 7-days]
  • Neutrophil Activity [Time frame: 7 days]
  • Evidence of Clinical Vasospasm [Time frame: Up to 15-weeks]
  • ICU Length of Stay (LOS) [Time frame: Up to 15-weeks]
  • Hospital Length of Stay (LOS) [Time frame: Up to 15-weeks]
  • In-hospital mortality [Time frame: Up to 15-weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • MaineHealth — Portland

Identifiers

NCT: NCT06569212 · 2146714

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗