Magnesium vs Amiodarone for Atrial Fibrillation

(MAGNAM Trial)

Recruiting at 4 trial locations

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Digoxin, Anti-arrhythmics

Disqualifiers: Age <18, Pregnancy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-24 hours

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you have not taken digoxin or certain heart rhythm medications in the last 24 hours. If you are on these medications, you may need to stop them before participating.

What data supports the effectiveness of the drug Amiodarone for treating atrial fibrillation?

Research suggests that Magnesium Sulfate can help control heart rhythm and reduce the need for Amiodarone in treating atrial fibrillation, especially in critically ill patients. Magnesium Sulfate has been shown to work well with other heart rhythm drugs and can help lower heart rates in patients with new-onset atrial fibrillation. ^{1 2 3 4 5}

Is it safe to use magnesium or amiodarone for atrial fibrillation?

Magnesium sulfate and amiodarone have been used in critically ill patients with atrial fibrillation, and while amiodarone is effective, it is potentially toxic. Magnesium sulfate is considered safer and can reduce the need for amiodarone, but both have been used safely in various studies for heart rhythm issues. ^{1 2 3 4 6}

How does the drug Magnesium Sulfate differ from Amiodarone for treating atrial fibrillation?

Magnesium Sulfate is unique because it can help control heart rate and rhythm and may reduce the need for other antiarrhythmic drugs like Amiodarone, which can be potentially toxic. It is often used in critically ill patients and can act quickly, sometimes preventing the need for more aggressive treatments. ^{1 2 4 5 6}

Research Team

Brian Cuthbertson, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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.

Inclusion Criteria

I have had a recent episode of fast heart rate over 120 beats per minute due to atrial fibrillation.

I can have heart monitoring as part of my care.

My doctor says I need treatment for my irregular heartbeat.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 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

6-24 hours

Continuous monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including heart rate control and restoration of normal sinus rhythm

Up to 90 days

Regular assessments during ICU stay and at discharge

Long-term follow-up

Continuation of trial intervention and monitoring for secondary outcomes such as hospital mortality and serious adverse events

Up to 90 days

Treatment Details

Interventions

• Amiodarone
• Digoxin
• Magnesium Sulfate

Trial Overview 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.

Participant Groups

Group I: Experimental arm Experimental Treatment 1 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 arm Active Control 1 Intervention

Intravenous amiodarone as compactor group intervention

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Sunnybrook Research Institute

Collaborator

Trials

33

Recruited

216,000+

Findings from Research

In a study of 29 critically ill patients with new-onset atrial fibrillation, magnesium sulfate (MgSO4) was effective in converting 16 patients to sinus rhythm, potentially reducing the need for the antiarrhythmic drug amiodarone.

The new treatment protocol, which involved an MgSO4 bolus followed by continuous infusion, achieved a 90% conversion rate to sinus rhythm within 24 hours, indicating both efficacy and safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of magnesium-amiodarone step-up scheme in critically ill patients with new-onset atrial fibrillation: a prospective observational study. Sleeswijk, ME., Tulleken, JE., Van Noord, T., et al.[2017]

In a study of 42 critically ill patients with atrial tachyarrhythmias, intravenous magnesium sulfate was found to be more effective than amiodarone in converting patients to sinus rhythm over a 24-hour period.

Both magnesium sulfate and amiodarone were equally effective in initially slowing the ventricular response rate in patients who did not convert to sinus rhythm, indicating that while magnesium is superior for conversion, both treatments can help manage heart rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenteral magnesium sulfate versus amiodarone in the therapy of atrial tachyarrhythmias: a prospective, randomized study. Moran, JL., Gallagher, J., Peake, SL., et al.[2019]

In a study involving 15 adults with newly recognized atrial fibrillation, parenteral magnesium sulfate (MgSO4) significantly reduced ventricular rates by 16% within 5 minutes, demonstrating its potential efficacy in acute management.

When combined with digoxin, the therapy showed a tendency for even greater rate control, suggesting that MgSO4 could be a valuable addition to treatment strategies for rapid ventricular rates in atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of magnesium sulfate on ventricular rate control in atrial fibrillation. Hays, JV., Gilman, JK., Rubal, BJ.[2019]

In a clinical trial involving 48 patients with new-onset rapid atrial fibrillation, intravenous magnesium sulfate (MgSO4) did not show a significant difference in reducing heart rate compared to a saline placebo after 2 hours.

Both treatment groups experienced a decrease in heart rate, but the rate of decrease and the proportion of patients converting to normal sinus rhythm were similar, indicating that MgSO4 may not be effective for this condition in the emergency department setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium sulfate versus placebo for paroxysmal atrial fibrillation: a randomized clinical trial. Chu, K., Evans, R., Emerson, G., et al.[2015]

In a study of 97 patients with symptomatic atrial fibrillation (AF), the use of Magnesium Sulfate (MgSO4) alongside flecainide resulted in a higher cardioversion rate (91.3%) compared to those who did not receive MgSO4 (80.4%).

While the combination of MgSO4 and flecainide did not show statistically significant improvements, MgSO4 was associated with a lower heart rate at the time of cardioversion and had a high safety profile, suggesting it may help reduce the need for more aggressive treatments in the emergency department.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Magnesium Sulfate Reduces the Need for Antiarrhythmics during Acute-Onset Atrial Fibrillation in Emergency and Critical Care. Gilardi, E., Pomero, F., Ravera, E., et al.[2022]

In a study of 438 patients undergoing lobectomy, both amiodarone and magnesium sulfate significantly reduced the incidence of atrial fibrillation (AF) compared to a control group, with amiodarone showing a slightly lower AF rate (10% vs. 12.5%).

Both medications also contributed to shorter intensive care unit and total hospital stays, indicating their effectiveness not only in preventing AF but also in improving overall recovery after lung surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study between amiodarone and magnesium sulfate as antiarrhythmic agents for prophylaxis against atrial fibrillation following lobectomy. Khalil, MA., Al-Agaty, AE., Ali, WG., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of magnesium-amiodarone step-up scheme in critically ill patients with new-onset atrial fibrillation: a prospective observational study. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Parenteral magnesium sulfate versus amiodarone in the therapy of atrial tachyarrhythmias: a prospective, randomized study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of magnesium sulfate on ventricular rate control in atrial fibrillation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Magnesium sulfate versus placebo for paroxysmal atrial fibrillation: a randomized clinical trial. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Intravenous Magnesium Sulfate Reduces the Need for Antiarrhythmics during Acute-Onset Atrial Fibrillation in Emergency and Critical Care. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

A comparative study between amiodarone and magnesium sulfate as antiarrhythmic agents for prophylaxis against atrial fibrillation following lobectomy. [2021]