Clinical trial NCT06569212: Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)
Official title: Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Non-Traumatic Subarachnoid Hemorrhage
Keywords: Beta-adrenergic blockade
Cardiac dysfunction
Inflammation
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: MaineHealth
First posted: 2024-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Delta QTc length
timeFrame: 7 days
measure: Delta neutrophil activity
timeFrame: 7 days
Secondary outcomes:
measure: Adverse events
timeFrame: 7-days
measure: Number of patients with evidence of cardiac injury
timeFrame: 7-days
measure: Need for Vasopressors
timeFrame: 7-days
measure: Sympathetic Nervous System (SNS) Activity
timeFrame: 7-days
measure: Neutrophil Activity
timeFrame: 7 days
measure: Evidence of Clinical Vasospasm
timeFrame: Up to 15-weeks
measure: ICU Length of Stay (LOS)
timeFrame: Up to 15-weeks
measure: Hospital Length of Stay (LOS)
timeFrame: Up to 15-weeks
measure: In-hospital mortality
timeFrame: Up to 15-weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: MaineHealth
state: Maine
Study officials:
affiliation: MaineHealth
name: Madeleine Puissant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: