MAGNAM Trial, Magnesium Versus Amiodarone in Atrial Fibrillation in Critical Care

Phase

Condition

Atrial Fibrillation

Chest Pain

Cardiac Disease

Treatment

Amiodarone

Magnesium sulfate and then Digoxin

Clinical Study ID

NCT05287191

3664

Ages > 18
All Genders

Study 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 inclusion/exclusion criteria at the time of the onset of fast atrial fibrillation (AF)(irregular and often rapid heart rate). The authors hypothesize that high dose Magnesium Sulphate with the addition of Digoxin as a second line treatment will improve the success rate in returning the heart to normal rhythm as well as speed of resolution of critical illness in new onset rapid atrial fibrillation in the critically ill cared for in general ICUs.

Eligibility Criteria

Inclusion

Inclusion Criteria: Each participant must meet all of the following inclusion criteria toparticipate in this study:

Admitted to a participating hospital ICU
A newly documented episode of fast Atrial Fibrillation with heart rate >120/minconfirmed by a 12-lead ECG assessment regardless of baseline rhythm (note- The AF canbe 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 requiresmedical treatment

Exclusion

Exclusion Criteria:

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 thepreceding 24 hours
MgSO4 dose of > 3g IV in the last 2 hours.
History of high grade Atrio-Ventricular conduction block or bradyarrhythmia withoutpacemaker
Non-cardiac indication or contraindication to one of the study treatments (hypertensive disorders of pregnancy, pre-term labour, neuromuscular junctiondisorders i.e. known Myasthenia gravis; documented prior history of amiodaronetoxicity or relative contraindication such as thyroid disease, cirrhosis, pulmonaryfibrosis, etc.)
Recent cardiac surgery during index hospital admission
Known pregnancy
Sustained (more than 10 continuous seconds documented on a rhythm strip) ventriculararrhythmia 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)

Study Design

Amiodarone

January 05, 2022

April 30, 2026

Study 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 to See Which is More Effective in Returning the Heart to Normal Rhythm After Experiencing Rapid Atrial Fibrillation in General ICUs. It will take place in Critical Care Units in Toronto Health Sciences Centres over a course of 2 years. The sample size is 200 patients.

Investigational Product and Planned Use Magnesium sulphate

The trial intervention will be Magnesium sulphate followed by digoxin as second line therapy with Amiodarone as third line. The Standard of care intervention will be Amiodarone as first line treatment in the and then no more than 2g MgSO4 be delivered.

Data will be collected retrospectively at the outcome timepoints.

Statistical Analysis:

This analysis will be conducted using the intention to treat principle, therefore all randomised patients will be included in the main analysis. Crossovers and protocol violations will remain in their original study group.

Baseline data will be summarized per group for continuous variables using means and standard deviations or medians and interquartile ranges as indicated the distribution and for discrete variables using frequencies and percentages. For the rate / rhythm co-primary outcome the authors will use a sentinel time point analysis at the 6 and 24 hour time points assuming there no / very low competing risk for death using a multivariate regression model to test for differences between groups and adjusting for baseline variables such as age, hospital site, shock status (requirement for inotropes Y/N), mechanical ventilation (Y/N) and known chronic atrial fibrillation. For the ICU length of stay co-primary outcome the authors recognise the competing risk of death and for this outcome and the authors propose to use Fine and Gray models adjusting for the stratification variables (as above). Estimates will be presented as sub-distribution hazards and 95% confidence intervals. The authors will test for interaction between sub-group and treatment and present the estimates per sub-group.

All secondary outcomes are binary and differences between groups will be tested using Chi square test or Fisher exact test as appropriate. Missing data will be uncommon for our key outcome data considering the nature of this data. The authors do not propose to use imputation for missing data in these primary or secondary analyses.

Connect with a study center

Mount Sinai Hospital
Toronto, Ontario M5G 1X5
Canada
Active - Recruiting
St Michael's Hospital
Toronto, Ontario M5B 1W8
Canada
Active - Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N3M5
Canada
Active - Recruiting
University Health Network - Toronto General Hospital
Toronto, Ontario M5G 2C4
Canada
Active - Recruiting
University Health Network - Toronto Western Hospital
Toronto, Ontario M5T 2S8
Canada
Active - Recruiting

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