Magnesium Sulfate for Rapid Heartbeat

(ATRIUM Trial)

Overseen By Marc McDowell, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Aurora Health Care

Must be taking: Diltiazem

Disqualifiers: Renal disease, Heart failure, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 hours

153 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are on diltiazem for heart rate control.

What data supports the effectiveness of the drug magnesium sulfate for rapid heartbeat?

Research shows that magnesium sulfate is effective in treating various types of rapid heartbeats, including those occurring after heart surgery and in conditions like supraventricular tachyarrhythmia (a type of fast heart rate). It has been used successfully to manage arrhythmias (irregular heartbeats) in different situations, demonstrating its potential as an effective treatment for rapid heartbeats. ^{1 2 3 4 5}

Is magnesium sulfate safe for treating rapid heartbeat?

Magnesium sulfate is generally safe for treating heart rhythm issues, but an overdose can cause serious side effects like slow heartbeat, low blood pressure, and breathing problems. It has been used safely in heart patients and after heart surgery with minimal side effects, but care must be taken to avoid dosing errors. ^{1 2 6 7 8}

How is the drug magnesium sulfate unique in treating rapid heartbeat?

Magnesium sulfate is unique because it can be used intravenously to treat both ventricular and supraventricular arrhythmias, especially when other treatments like adenosine fail. It works by stabilizing the heart's electrical activity, making it effective in conditions like torsade de pointes and arrhythmias caused by digitalis toxicity. ^{1 3 5 9 10}

What is the purpose of this trial?

The purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of AFF RVR.

Research Team

Travis Hase, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for individuals with a type of irregular heartbeat known as atrial fibrillation/flutter and rapid heart rate. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.

Inclusion Criteria

I am taking Diltiazem for heart rate control.

Primary diagnosis AFF RVR greater than or equal to 120 bpm

English speaking

Exclusion Criteria

Withdrew from study

Impaired consciousness

Previously enrolled in this trial during a different patient encounter

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous magnesium or placebo to evaluate safety and efficacy in treating AFF RVR

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including heart rate changes and adverse effects

24 hours

Treatment Details

Interventions

• Magnesium Sulfate

Trial Overview The study is testing the effects of two different doses of intravenous magnesium (2g and 4g) compared to a saline placebo in managing atrial fibrillation with a rapid ventricular response. It's set up so neither the patients nor the doctors know who gets which treatment.

Participant Groups

Group I: Experimental Arm Two, Magnesium Sulfate 4g Experimental Treatment 1 Intervention

Magnesium Sulfate 4g/50ml 0.9% NaCl

Group II: Experimental Arm One, Magnesium Sulfate 2g Experimental Treatment 1 Intervention

Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)

Group III: Control Arm, normal saline Placebo Group 1 Intervention

50ml 0.9% NaCl

Magnesium Sulfate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment
• Constipation treatment

Approved in European Union as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

Approved in Canada as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment

Who Is Running the Clinical Trial?

Aurora Health Care

Lead Sponsor

Trials

46

Recruited

16,400+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

Magnesium sulphate was found to be effective in managing ventricular arrhythmias in 28 patients with heart failure undergoing digitalis therapy, allowing continued digitalis treatment until cardiac function improved.

The study suggests that magnesium sulphate's anti-arrhythmic properties help mitigate the complications of digitalis therapy, although the specific mechanism of action in this context is explored further in the paper.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anti-arrhythmic effect of magnesium cations. Protection against ventricular excitability during cardiotonic therapy]. Critelli, G., Ferro, G., Adinolfi, L., et al.[2013]

In a study of 100 patients with arrhythmias after cardiac surgery, magnesium sulfate was found to be an effective antiarrhythmic agent, showing a 56% effectiveness rate compared to 74% for standard agents like lidocaine and amiodarone, although this difference was not statistically significant.

Magnesium sulfate was particularly more effective in patients with low magnesium levels and in cases of ventricular arrhythmias, suggesting its potential as a first-line treatment without the need for routine blood level monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiarrhythmic effect of magnesium sulfate after open heart surgery: effect of blood levels. Kiziltepe, U., Eyileten, ZB., Sirlak, M., et al.[2019]

Magnesium therapy has been shown to be effective in treating intractable ventricular tachycardia and ventricular fibrillation, even in patients with normal magnesium levels, as well as in cases of 'torsades de pointes' and digoxin intoxication.

Parenteral magnesium sulfate administration was found to be safe and effective for controlling ventricular rates in multifocal atrial tachycardia, with specific dosing guidelines provided for patients without renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium and cardiac arrhythmias. Iseri, LT.[2013]

Magnesium sulfate treatment was effective in terminating various types of supraventricular tachyarrhythmias (SVTA) in a study of 25 cases, with significant improvements observed in conditions like paroxysmal supraventricular tachycardia (PSVT) and chaotic atrial tachycardia (CAT).

The treatment showed rapid effects, with many patients experiencing recovery within hours to days after intravenous infusion, indicating magnesium sulfate's potential as a safe and effective intervention for managing SVTA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical effects of magnesium sulfate in the treatment of supraventricular tachyarrhythmia]. Shao, M.[2016]

Magnesium sulphate has been successfully used as an antiarrhythmic agent in three different patients with arrhythmias affecting their heart function, demonstrating its versatility beyond just treating torsade de pointe.

The cases highlight that magnesium sulphate can effectively treat both ventricular arrhythmias and serve as a second-line treatment for supraventricular arrhythmias, suggesting its potential broader application in various arrhythmic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiarrhythmic effects of magnesium sulphate. Report of three cases. Knudsen, K., Abrahamsson, J.[2019]

In a study of eight normomagnesemic patients, intravenous magnesium sulfate (MgSO4) significantly increased serum magnesium levels and prolonged key ECG intervals, indicating its potential to affect heart conduction.

The observed prolongation of the PR interval and other conduction times suggests that magnesium may help treat certain arrhythmias by blocking slow sodium channels, although it did not significantly impact other cardiac conduction parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiologic effects of intravenous magnesium in patients with normal conduction systems and no clinical evidence of significant cardiac disease. Kulick, DL., Hong, R., Ryzen, E., et al.[2019]

A 73-year-old man experienced an iatrogenic overdose of magnesium sulfate during treatment for suspected acute myocardial infarction, leading to serious side effects like bradycardia, hypotension, and apnea.

This case highlights the need for better education among emergency department staff regarding proper dosing and potential adverse effects of magnesium sulfate, especially since such overdoses in cardiac patients have not been previously reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iatrogenic magnesium overdose in a patient with suspected acute myocardial infarction. Frohna, WJ.[2012]

Magnesium sulfate (MgSO4) treatment in obstetrics has been associated with negative effects on the fetus and newborn, raising concerns about its safety in these populations.

There are conflicting reports regarding the tocolytic efficacy of magnesium sulfate, meaning its effectiveness in stopping preterm labor is still debated among researchers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency and safety of magnesium sulfate treatment in obstetrics]. Mikołajek, W., Chlubek, D.[2017]

A review of 59 studies involving 21,149 eclamptic women found that a significant number (25%) had normal blood pressure or mild-to-moderate hypertension before experiencing seizures, suggesting that eclampsia can occur even without severe hypertension.

The findings support the idea of administering magnesium sulfate prophylactically to all women with mild pre-eclampsia, as many women showed symptoms like headaches and visual disturbances prior to convulsions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should magnesium sulfate be administered to women with mild pre-eclampsia? A systematic review of published reports on eclampsia. Berhan, Y., Berhan, A.[2022]

Magnesium sulfate infusion can be an effective treatment for certain types of cardiac dysrhythmias, as demonstrated in a case where a 38-year-old firefighter's atrial tachycardia was successfully converted to normal sinus rhythm after unsuccessful treatment with IV adenosine.

The administration of 2 g of magnesium sulfate over 5 minutes led to complete resolution of the patient's symptoms, suggesting its potential as a rapid intervention for managing supraventricular tachycardia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium sulfate for conversion of supraventricular tachycardia refractory to intravenous adenosine. LeDuc, TJ., Carr, JD.[2019]

References

1. France pubmed.ncbi.nlm.nih.gov

[Anti-arrhythmic effect of magnesium cations. Protection against ventricular excitability during cardiotonic therapy]. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Antiarrhythmic effect of magnesium sulfate after open heart surgery: effect of blood levels. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Magnesium and cardiac arrhythmias. [2013]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical effects of magnesium sulfate in the treatment of supraventricular tachyarrhythmia]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Antiarrhythmic effects of magnesium sulphate. Report of three cases. [2019]

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

Electrophysiologic effects of intravenous magnesium in patients with normal conduction systems and no clinical evidence of significant cardiac disease. [2019]

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

Iatrogenic magnesium overdose in a patient with suspected acute myocardial infarction. [2012]

8. Poland pubmed.ncbi.nlm.nih.gov

[Efficiency and safety of magnesium sulfate treatment in obstetrics]. [2017]

9. Australia pubmed.ncbi.nlm.nih.gov

Should magnesium sulfate be administered to women with mild pre-eclampsia? A systematic review of published reports on eclampsia. [2022]

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

Magnesium sulfate for conversion of supraventricular tachycardia refractory to intravenous adenosine. [2019]