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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
MAGNAM Trial Summary
This trial will compare magnesium sulfate to magnesium sulfate + digoxin to see which is more effective in treating atrial fibrillation.
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.Check my eligibility
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.See study design
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.
MAGNAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a recent episode of fast heart rate over 120 beats per minute due to atrial fibrillation.
MAGNAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate control (<110 beats per minute) and/or restoration of normal sinus
ICU free days
Secondary outcome measures
Avoidance of amiodarone
Continuation of trial intervention
Heart rate
+3 moreMAGNAM 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 AF
Group II: Standard of care armActive Control1 Intervention
Intravenous amiodarone as compactor group intervention
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,237 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
5,735 Patients Enrolled for Atrial Fibrillation
Sunnybrook Research InstituteOTHER
31 Previous Clinical Trials
215,619 Total Patients Enrolled
Brian H Cuthbertson, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have chosen to focus on comfort care, or are expected to pass away within the next 12 hours.I have a history of serious heart rhythm problems without a pacemaker.Your potassium levels are consistently too high, even with treatment.I have received more than 3 grams of IV magnesium sulfate in the last 2 hours.I have taken digoxin or anti-arrhythmic medication in the last 24 hours.My heart has been beating very fast for more than 2 days.I have had a recent episode of fast heart rate over 120 beats per minute due to atrial fibrillation.I do not have conditions like high blood pressure during pregnancy, early labor, muscle nerve disorders, thyroid disease, liver cirrhosis, or lung scarring that would prevent me from receiving the study treatment.I can have heart monitoring as part of my care.I have had a lung transplant during my current hospital stay.I had a heart rhythm problem lasting more than 10 seconds in the last day.You have participated in the MAGNAM trial before.My doctor says I need treatment for my irregular heartbeat.I had heart surgery during my current hospital stay.You have a known or suspected heart condition called pre-excitation syndrome.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care arm
- Group 2: Experimental arm
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please tell me how many people are taking part in this experimental procedure?
"That is accurate. The listing on clinicaltrials.gov says that this trial, which was first posted on January 5th 2022, is currently looking for 200 patients at 1 site."
Answered by AI
Has the FDA greenlit the use of Magnesium sulfate in tandem with Digoxin?
"There is some evidence from past trials to support the efficacy of magnesium sulfate and digoxin, so these drugs were given a safety score of 3."
Answered by AI
Who else is applying?
What site did they apply to?
Mount Sinai Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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