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Antiarrhythmic Agent

Magnesium vs Amiodarone for Atrial Fibrillation (MAGNAM Trial)

Phase 3
Recruiting
Led By Brian H Cuthbertson, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A newly documented episode of fast AF with HR >120/min confirmed by a 12-lead ECG assessment regardless of baseline rhythm (note- The AF can be acute or chronic diagnosis)
Be older than 18 years old
Must not have
MgSO4 dose of > 3g IV in the last 2 hours
Fast AF (>120/min) present for > 48 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial tests if giving magnesium first, followed by digoxin, and using amiodarone as a backup is better at restoring normal heart rhythm in critically ill ICU patients with rapid heartbeats. Amiodarone has been used successfully in patients with heart conditions.

Who is the study for?
The MAGNAM trial is for adults in critical care with a new or existing diagnosis of fast atrial fibrillation (heart rate over 120/min) who need medical treatment. They must be able to have heart monitoring and not have used certain heart medications recently, nor should they have specific heart conditions, be pregnant, or critically ill with life expectancy under 12 hours.
What is being tested?
This study tests if high-dose Magnesium Sulfate followed by Digoxin can more effectively restore normal heart rhythm compared to Amiodarone in patients with rapid atrial fibrillation. It's a randomized controlled trial across multiple centers where patients are chosen at random to receive one of the treatments.
What are the potential side effects?
Possible side effects include flushing and sweating from Magnesium Sulfate; nausea, vomiting, and confusion from Digoxin; and Amiodarone may cause lung issues, liver problems, thyroid dysfunction or skin changes due to sun exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a recent episode of fast heart rate over 120 beats per minute due to atrial fibrillation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received more than 3 grams of IV magnesium sulfate in the last 2 hours.
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My heart has been beating very fast for more than 2 days.
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I have taken digoxin or anti-arrhythmic medication in the last 24 hours.
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I have a history of serious heart rhythm problems without a pacemaker.
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I have had a lung transplant during my current hospital stay.
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I had a heart rhythm problem lasting more than 10 seconds in the last day.
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I had heart surgery during my current hospital stay.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Heart rate control (<110 beats per minute) and/or restoration of normal sinus
ICU free days
Secondary study objectives
Avoidance of amiodarone
Continuation of trial intervention
Heart rate
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental armExperimental Treatment1 Intervention
Intravenous magnesium sulphate as first line followed by digoxin IV loading as second line and then amiodarone IV as third line treatments for fast Atrial Fibrillation
Group II: Standard of care armActive Control1 Intervention
Intravenous amiodarone as compactor group intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Magnesium Sulphate stabilizes cardiac cell membranes and reduces excitability, helping to prevent abnormal electrical activity that can lead to Atrial Fibrillation (AF). Digoxin increases vagal tone and decreases conduction through the AV node, which slows the heart rate and helps control the ventricular response in AF. These mechanisms are crucial for AF patients as they directly address the irregular heart rhythms and high heart rates that characterize AF, improving symptoms and reducing the risk of complications.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,558 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
5,716 Patients Enrolled for Atrial Fibrillation
Sunnybrook Research InstituteOTHER
32 Previous Clinical Trials
215,598 Total Patients Enrolled
Brian H Cuthbertson, MDPrincipal InvestigatorSunnybrook Health Sciences Centre

Media Library

Amiodarone (Antiarrhythmic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05287191 — Phase 3
Atrial Fibrillation Research Study Groups: Standard of care arm, Experimental arm
Atrial Fibrillation Clinical Trial 2023: Amiodarone Highlights & Side Effects. Trial Name: NCT05287191 — Phase 3
Amiodarone (Antiarrhythmic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05287191 — Phase 3
~44 spots leftby Oct 2025