Recruiting

Beta-1 Adrenergic Inhibition

Sponsor:

Madeleine Puissant

Code:

NCT06569212

Conditions

Non-Traumatic Subarachnoid Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Metoprolol

Placebo

Study Details

Brief summary:

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

Conditions

Non-Traumatic Subarachnoid Hemorrhage

Study ID

NCT06569212

Start date

Sep 23, 2024

Status verified date

Nov, 2024

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Metoprolol (Beta-adrenergic blockade)

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

placebo comparator: Placebo

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

Interventions

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

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 measure

  • Delta QTc length [ Time Frame: 7 days ]
  • Delta neutrophil activity [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Madeleine Puissant, MD, PhD

2076613660Madeleine.Puissant@mainehealth.org

Christine Lord

Christine.Lord@mainehealth.org

Locations

MaineHealth

Recruiting

Portland, Maine, United States, 04012

Contacts

Christine Lord

2076613660christine.lord@mainehealth.org

More Information

Sponsor

Madeleine Puissant

Last update posted

Nov 26, 2024

Last verified

Nov, 2024

Keywords

  • Beta-adrenergic blockade
  • Cardiac dysfunction
  • Inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Madeleine Puissant on 2024-11-26.