Status:
RECRUITING
MAGNAM Trial, Magnesium Versus Amiodarone in Atrial Fibrillation in Critical Care
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Sunnybrook Research Institute
Conditions:
Atrial Fibrillation New Onset
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A multi-centre, non-blinded, comparative effectiveness, randomised controlled trial. Patients will be prospectively enrolled from Critical Care Units and will be assessed for study enrollment based on...
Detailed Description
This is a Multi-centre, randomised controlled, clinical trial that is comparing a Stepwise Strategy of Magnesium Followed by Digoxin, With an Amiodarone Backup vs a Strategy of First-line Amiodarone t...
Eligibility Criteria
Inclusion
- Each participant must meet all of the following inclusion criteria to participate in this study:
- Admitted to a participating hospital ICU
- A newly documented episode of fast Atrial Fibrillation with heart rate \>120/min confirmed by a 12-lead ECG assessment regardless of baseline rhythm (note- The AF can be acute or chronic diagnosis)
- Undergoing, or able to commence continuous electrocardiographic monitoring ("telemetry") as part of their routine clinical care
- Treating physician determines the patient has clinically significant AF that requires medical treatment
Exclusion
- Age \<18 years
- Palliative goals of care or expected to die in the next 12 hours
- Fast Atrial Fibrillation (\>120/min) present for \> 48 hours
- Treatment with digoxin or a class I or III anti-arrhythmic medication within the preceding 24 hours
- MgSO4 dose of \> 3g IV in the last 2 hours.
- History of high grade Atrio-Ventricular conduction block or bradyarrhythmia without pacemaker
- Non-cardiac indication or contraindication to one of the study treatments (hypertensive disorders of pregnancy, pre-term labour, neuromuscular junction disorders i.e. known Myasthenia gravis; documented prior history of amiodarone toxicity or relative contraindication such as thyroid disease, cirrhosis, pulmonary fibrosis, etc.)
- Recent cardiac surgery during index hospital admission
- Known pregnancy
- Sustained (more than 10 continuous seconds documented on a rhythm strip) ventricular arrhythmia within the past 24 hours
- Known or suspected pre-excitation syndrome
- Persistent hyperkalemia \> 6mmol/l despite treatment
- Previously enrolled in the MAGNAM trial
- Recent lung transplantation (during this admission)
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05287191
Start Date
January 5 2022
End Date
April 30 2026
Last Update
April 25 2024
Active Locations (5)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
2
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
3
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
4
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4