Non-Traumatic Subarachnoid HemorrhagePhase 4BADCATSNCT06569212
Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)
A Phase 4 study testing Metoprolol in people with Non-Traumatic Subarachnoid Hemorrhage, run by Madeleine Puissant at 1 site in United States.
Trial summary
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Traumatic Subarachnoid Hemorrhage
- What is being tested?
- Metoprolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Neuro-imaging confirmed non-traumatic subarachnoid hemorrhage
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).
Read the 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.
- Conditions
- Non-Traumatic Subarachnoid Hemorrhage
- Being tested
- Metoprolol, Placebo
- Keywords
- Beta-adrenergic blockade, Cardiac dysfunction, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Also called Metoprolol succinate
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol (Beta-adrenergic blockade) | Experimental | Patients will receive metoprolol during the first 72-hours of hospitalization after non-traumatic SAH. Receives: Drug: Metoprolol |
| Placebo | Placebo comparator | Patients will receive placebo during the first 72-hours of hospitalization after non-traumatic SAH. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta QTc length
Change (Delta) QTc length between intervention and control groups.
Measured: 7 days
Delta neutrophil activity
Delta neutrophil activity between intervention and control groups.
Measured: 7 days
Secondary outcomes (9)
Adverse events
Including but not limited to symptomatic bradycardia, symptomatic hypotension, or complete heart block
Measured: 7-days
Number of patients with evidence of cardiac injury
Measurement of troponin levels, echocardiograph
Measured: 7-days
Need for Vasopressors
Any documented intravenous vasoactive medication administration
Measured: 7-days
Sympathetic Nervous System (SNS) Activity
Catecholamine Measurements
Measured: 7-days
Neutrophil Activity
Measurement of neutrophils in CSF and serum samples
Measured: 7 days
Evidence of Clinical Vasospasm
Evidence of clinical vasospasm
Measured: Up to 15-weeks
ICU Length of Stay (LOS)
Number of full days
Measured: Up to 15-weeks
Hospital Length of Stay (LOS)
Number of full days
Measured: Up to 15-weeks
In-hospital mortality
Whether patient died during during sentinel hospitalization
Measured: Up to 15-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start23 Sep 2024
- Primary completion30 Sep 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Traumatic Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madeleine Puissant
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth
- Responsible party
- Sponsor-investigator, Madeleine Puissant, MaineHealth
- Investigators
- Madeleine Puissant, MD, PhD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569212
- Sponsor's protocol ID
- 2146714
- Acronym
- BADCATS
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)
- ClinicalTrials.gov ID
- NCT06569212
- Acronym / sponsor ID
- BADCATS / 2146714
- Conditions
- Non-Traumatic Subarachnoid Hemorrhage
- Keywords
- Beta-adrenergic blockade, Cardiac dysfunction, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Madeleine PuissantUniversity, hospital or other
- Collaborators
- MaineHealth
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoprolol (Beta-adrenergic blockade) | Experimental | Drug: MetoprololPatients will receive metoprolol during the first 72-hours of hospitalization after non-traumatic SAH. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo during the first 72-hours of hospitalization after non-traumatic SAH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- Neuro-imaging confirmed non-traumatic subarachnoid hemorrhage
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoprololAlso: Metoprolol succinateMetoprolol 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 | Drug | Metoprolol (Beta-adrenergic blockade) |
| PlaceboPlacebo 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 | Drug | Placebo |
Primary outcome
Delta QTc length
Time frame: 7 days
Change (Delta) QTc length between intervention and control groups.
Delta neutrophil activity
Time frame: 7 days
Delta neutrophil activity between intervention and control groups.
9 secondary outcomes
Adverse events
Time frame: 7-days
Number of patients with evidence of cardiac injury
Time frame: 7-days
Need for Vasopressors
Time frame: 7-days
Sympathetic Nervous System (SNS) Activity
Time frame: 7-days
Neutrophil Activity
Time frame: 7 days
Evidence of Clinical Vasospasm
Time frame: Up to 15-weeks
ICU Length of Stay (LOS)
Time frame: Up to 15-weeks
Hospital Length of Stay (LOS)
Time frame: Up to 15-weeks
In-hospital mortality
Time frame: Up to 15-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madeleine Puissant, MD, PhD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol in people with Non-Traumatic Subarachnoid Hemorrhage, run by Madeleine Puissant at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta QTc length (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.