MaineHealth
Not reportedPortland, Maine, 04012, United States
Contact details are not published in this record. Check official study record ↗
CLINICAL STUDY · NCT06569212
Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)
Active, not recruitingPhase 4Interventional
Sponsored by Madeleine Puissant
- Condition
- Non-Traumatic Subarachnoid Hemorrhage
- Study locations
- 1 reported site
- Study updated
- 19 Oct 2026
- Source
- ClinicalTrials.gov
Overall study status is shown above. Individual hospitals may have a different recruitment status.
THE STUDY
About this study
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.
PARTICIPATION
Who may participate
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex eligibility
- All sexes
- Healthy volunteers
- Not accepted
Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.
Full inclusion and exclusion 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
* \>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
NEAR YOU
Study locations worldwide
1 siteCheck the individual site’s status and contact the listed study team for current availability.
1 site shown
No centres match this search. Try another hospital, city, state or country.
WHAT IS BEING STUDIED
Treatments and study groups
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
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
Study groups: Metoprolol (Beta-adrenergic blockade)
Other names: Metoprolol succinate
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
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
Study groups: Placebo
Study groups
Metoprolol (Beta-adrenergic blockade)
Patients will receive metoprolol during the first 72-hours of hospitalization after non-traumatic SAH.
Interventions: Drug: Metoprolol
Placebo
Patients will receive placebo during the first 72-hours of hospitalization after non-traumatic SAH.
Interventions: Drug: Placebo
RESEARCH DETAILS
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomized
- Study model
- Parallel
- Masking
- None (open label)
- Enrolment
- 20 participants · Estimated
TIMELINE & MEASURES
Dates and outcomes
- Study started
- 23 Sep 2024 · Actual
- Primary completion
- 30 Sep 2027 · Estimated
- Study completion
- Sep 2029 · Estimated
- First registered
- 23 Aug 2024 · Actual
- Last registry update
- 19 Oct 2026 · Actual
- Status last verified
- Oct 2026
Primary outcomes (2)
Delta QTc length
Change (Delta) QTc length between intervention and control groups.
Time frame: 7 days
Delta neutrophil activity
Delta neutrophil activity between intervention and control groups.
Time frame: 7 days
Secondary outcomes (9)
Adverse events
Including but not limited to symptomatic bradycardia, symptomatic hypotension, or complete heart block
Time frame: 7-days
Number of patients with evidence of cardiac injury
Measurement of troponin levels, echocardiograph
Time frame: 7-days
Need for Vasopressors
Any documented intravenous vasoactive medication administration
Time frame: 7-days
Sympathetic Nervous System (SNS) Activity
Catecholamine Measurements
Time frame: 7-days
Neutrophil Activity
Measurement of neutrophils in CSF and serum samples
Time frame: 7 days
Evidence of Clinical Vasospasm
Evidence of clinical vasospasm
Time frame: Up to 15-weeks
ICU Length of Stay (LOS)
Number of full days
Time frame: Up to 15-weeks
Hospital Length of Stay (LOS)
Number of full days
Time frame: Up to 15-weeks
In-hospital mortality
Whether patient died during during sentinel hospitalization
Time frame: Up to 15-weeks
STUDY TEAM
Sponsor and contacts
- Lead sponsor
- Madeleine Puissant
- Sponsor type
- Other
- Collaborators
- MaineHealth
- Organisation study ID
- 2146714
Central study contacts
No central contact is currently reported. Check the site contacts or the official record.
Study officials
Madeleine Puissant, MD, PhDPrincipal investigator · MaineHealth
Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.
FURTHER READING
Results, documents and references
No results are posted in this registry record
This does not mean the study has no findings. Results may not yet have been submitted or published here.
No study documents are listed in this record.