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NCT Number: NCT06569212

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MaineHealth

Portland, Maine, 04012, United States

Location status: Recruiting

Location contact

Christine Lord

CONTACT

[email protected]

2076613660

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Metoprolol succinate

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

Primary outcomes

  1. Delta QTc length

    Time frame: 7 days

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

  2. Delta neutrophil activity

    Time frame: 7 days

    Delta neutrophil activity between intervention and control groups.

Secondary outcomes

  1. Adverse events

    Time frame: 7-days

    Including but not limited to symptomatic bradycardia, symptomatic hypotension, or complete heart block

  2. Number of patients with evidence of cardiac injury

    Time frame: 7-days

    Measurement of troponin levels, echocardiograph

  3. Need for Vasopressors

    Time frame: 7-days

    Any documented intravenous vasoactive medication administration

  4. Sympathetic Nervous System (SNS) Activity

    Time frame: 7-days

    Catecholamine Measurements

  5. Neutrophil Activity

    Time frame: 7 days

    Measurement of neutrophils in CSF and serum samples

  6. Evidence of Clinical Vasospasm

    Time frame: Up to 15-weeks

    Evidence of clinical vasospasm

  7. ICU Length of Stay (LOS)

    Time frame: Up to 15-weeks

    Number of full days

  8. Hospital Length of Stay (LOS)

    Time frame: Up to 15-weeks

    Number of full days

  9. In-hospital mortality

    Time frame: Up to 15-weeks

    Whether patient died during during sentinel hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Lord

CONTACT

[email protected]

Madeleine Puissant, MD, PhD

CONTACT

[email protected]

2076613660

Sponsors and collaborators

Lead sponsor

Madeleine Puissant

Other

Collaborators

  • MaineHealth

Registry information

Acronym: BADCATS

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Aug 23, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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