Using metoprolol to reduce heart and brain damage after a type of brain hemorrhage
Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)
This study is testing if giving metoprolol right after a brain bleed can help protect the heart and brain in patients who have had a subarachnoid hemorrhage.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MaineHealth Academic / other |
| Locations | 1 site (Portland, Maine) |
| Trial ID | NCT06569212 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the effects of early administration of metoprolol, a beta-adrenergic blocker, in patients who have experienced non-traumatic subarachnoid hemorrhage (SAH). The study will compare two groups: one receiving metoprolol and the other receiving a placebo, focusing on various outcomes such as sympathetic nervous system activation, cardiac rhythm abnormalities, and biomarkers of tissue damage and inflammation. Participants will be monitored for 72 hours post-SAH to assess the impact of the intervention on both cardiac and brain health.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with neuro-imaging confirmed non-traumatic subarachnoid hemorrhage.
Not a fit: Patients with traumatic subarachnoid hemorrhage or unstable vital signs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce cardiac injury and inflammation in patients after a subarachnoid hemorrhage.
How similar studies have performed: While the specific application of metoprolol in this context is novel, previous studies have shown promise in using beta-blockers for cardiac protection in various settings.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Portland, Maine
- MaineHealth — Portland, Maine, United States (Recruiting)
Study contacts
- Principal investigator: Madeleine Puissant, MD, PhD — MaineHealth
- Study coordinator: Madeleine Puissant, MD, PhD
- Email: Madeleine.Puissant@mainehealth.org
- Phone: 2076613660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.