Magnesium Sulfate for Rapid Heartbeat

(ATRIUM Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Travis Hase, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Aurora Health Care

Must be taking: Diltiazem

Disqualifiers: Renal disease, Heart failure, Pregnancy, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

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.

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.

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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.

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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.

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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

Trial 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

Participant Groups

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.

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, Australia 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

🇦🇺 Approved in Australia as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Advocate Christ Medical Center Emergency Department (ACMC ED) Oak Lawn, IL

Who Is Running the Clinical Trial?

Aurora Health Care Lead Sponsor

Wake Forest University Health Sciences Lead Sponsor

References

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

[Anti-arrhythmic effect of magnesium cations. Protection against ventricular excitability during cardiotonic therapy]. [2013] This study showed the effectiveness of magnesium sulphate during digitalis therapy complicated by ventricular hyperexcitability. 28 patients with cardiac disease and ventricular arrhythmias in heart failure were studied. Magnesium sulphate was given by slow intravenous infusion (30--50 mg/min) twice daily. The anti-arrhytmic action allowed treatment with digitalis until improvement in cardiac function was observed. The mechanism of the action of magnesium sulphate in digitalis--induced arrhythmias is discussed.

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

Antiarrhythmic effect of magnesium sulfate after open heart surgery: effect of blood levels. [2019] Arrhythmias following cardiac surgery is still a difficult complication to treat. Magnesium sulfate is an effective antiarrhythmic agent with negligible side effects. In this study, effects of magnesium sulfate as a first line antiarrhythmic agent was compared with results of two different well-accepted antiarrhythmic agents.

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

Magnesium and cardiac arrhythmias. [2013] The effectiveness of magnesium therapy in intractable ventricular tachycardia and ventricular fibrillation was documented in patients not only with hypomagnesemia, but also in patients with normomagnesemia. It was also effective in ventricular tachycardia characterized by 'torsades de pointes' and in massive digoxin intoxication. Prospectively, parenteral magnesium therapy was also effective in controlling the ventricular rate in multifocal atrial tachycardia (8 patients) by reducing the number and the rate of ectopic atrial foci. Parenteral magnesium sulfate administration, 10-15 ml of 20% MgSO4 in 1 min and 500 ml of 2% MgSO4 in 5 h in patients without renal failure was found to be safe and effective. Magnesium sulfate prevented hyperpotassemia in massive digoxin intoxication and tended to produce hypopotassemia in other patients necessitating concomitant use of potassium chloride.

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

[Clinical effects of magnesium sulfate in the treatment of supraventricular tachyarrhythmia]. [2016] The obvious effects of magnesium sulfate are noticed not only in ventricular tachyarrhythmia but also in supraventricular tachyarrhythmia (SVTA) which include paroxysmal supraventricular tachycardia (PSVT), chaotic atrial tachycardia (CAT), atrial fibrillation (AF) with rapid heart rate and nonparoxysmal junctional tachycardia (NPJT). This paper reports the effects of magnesium sulfate treatment in 25 cases of SVTA in a self-controlled before and after study. Among 10 cases of PSVT, 6 cases were treated by injection of 25% magnesium sulfate 5-10 ml. Except 2 cases with W-P-W and aberrant ventricular condition, the PS-VT were terminated immediately after half a dose of magnesium sulfate i.v. in 2 cases, other 2 cases were terminated by 5-10 min after a dose of magnesium sulfate i.v.. Some improvements were observed in these 4 cases. The rest 4 cases were prevented by 12 days' intravenous infusion of 1% magnesium sulfate 250 ml per day, 3 cases of them recovered. Three cases of CAT recovered within an hour to two days by infusion of 1% magnesium sulfate 250 ml. Four cases of AF with rapid heart rate were collected, even though it is difficult to determine whether it is due to overdose or inadequacy of digitalis. The heart rates were reduced by magnesium sulfate injection in those 4 cases. Eight cases of NPJT due to heart failure with digitalis intoxication recovered after infusion of 1% magnesium sulfate 250ml within 10 hours to two days. Finally, the mechanism of the effect of magnesium sulfate treatment in SVTA was discussed.

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

Antiarrhythmic effects of magnesium sulphate. Report of three cases. [2019] A wide variety of antiarrhythmic agents is used in treatment of both supraventricular and ventricular arrhythmias. Magnesium sulphate has previously been used mainly in the treatment of torsade de pointe arrhythmias but several reports show that this agent may be used in the treatment of arrhythmias of different aetiology. We describe 3 patients who exhibited arrhythmias affecting haemodynamic performance. Case #1 had a subarachnoid haemorrhage and developed a supraventricular tachycardia. In case #2, ventricular tachycardia appeared during the postoperative course after abdominal surgery. Case #3 experienced critical heart failure due to dilated cardiomyopathy and had an irregular heart rhythm with multiple ectopic beats. In all three cases the administration of intravenous magnesium sulphate was successful in treating the arrhythmias. Magnesium sulphate is an antiarrhythmic agent that is effective mainly in treatment of ventricular arrhythmias. The drug can also be employed as second-line treatment of supraventricular arrhythmias.

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] Parenteral magnesium has been used for several decades in the empiric treatment of various arrhythmias, but the data on its electrophysiologic effects in man are limited. We evaluated the electrophysiologic effects of magnesium sulfate (MgSO4) administration in eight normomagnesemic patients with normal mononuclear cell magnesium content, who had no clinically significant heart disease and had normal baseline electrophysiologic properties. After administration of intravenous MgSO4, serum magnesium rose significantly from 1.9 +/- 0.1 to 4.4 +/- 1.7 mg/dl (p less than 0.02). During a maintenance magnesium infusion, we observed significant prolongation of the ECG PR interval (145 +/- 18 to 155 +/- 26 msec, p less than 0.05), AH interval (77 +/- 27 to 83 +/- 26 msec, p less than 0.002), antegrade atrioventricular (AV) nodal effective refractory period (278 +/- 67 to 293 +/- 67 msec, p less than 0.05), and sinoatrial conduction time (60 +/- 34 to 76 +/- 32 msec, p less than 0.02). No significant effect was observed on sinus cycle length, sinus node recovery time, intra-atrial or intraventricular conduction times, QRS duration (during both sinus rhythm and ventricular pacing), QT interval, HV interval, paced cycle length resulting in AV nodal Wenckebach block, AV nodal functional refractory period, retrograde ventriculoatrial (VA) effective refractory period, or atrial and ventricular refractory periods. These findings, in conjunction with the demonstrated ability of magnesium to block slow channels for sodium movement, may provide an explanation of the mechanism by which magnesium exerts its effect in the treatment of atrial and junctional arrhythmias.

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

Iatrogenic magnesium overdose in a patient with suspected acute myocardial infarction. [2012] A case of iatrogenic, parenteral overdose of magnesium sulfate in a patient with suspected acute myocardial infarction is presented. A 73-year-old man presented with a history and physical examination consistent with suspected acute myocardial infarction and congestive heart failure. During the patient's treatment in the emergency department (ED), the physician ordered 2 g magnesium sulfate intravenously. The nurse mistakenly administered "two amps" (two 25-g single-dose vials) of magnesium sulfate intravenously. The patient developed bradycardia, hypotension, and apnea during the infusion. Although the use and inadvertent misuse of magnesium salts in obstetrics is well known, iatrogenic overdose in a patient with cardiac indications for magnesium has not been previously reported. Personnel responsible for the administration of medications in the ED must be educated about the dosing regimens and adverse effects associated with magnesium.

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

[Efficiency and safety of magnesium sulfate treatment in obstetrics]. [2017] Current views on efficacy and safety of magnesium sulfate treatment in obstetrics are presented. Negative effects of MgSO4 on fetus and newborn are described. Contradictory reports dealing with tocolytic efficacy of magnesium sulfate are discussed.

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] Magnesium sulfate is an evidence-based anticonvulsant drug used to prevent and control eclampsia. Controversy persists on routine administration of magnesium sulfate in cases of pre-eclampsia without severe features. Our objective was to assess the pattern of blood pressure and maternal symptoms preceding eclamptic seizure based on the current published work.

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

Magnesium sulfate for conversion of supraventricular tachycardia refractory to intravenous adenosine. [2019] The use of magnesium sulfate infusion for the management of cardiac dysrhythmia has recently gained popularity. Magnesium sulfate has been advocated for the management of torsade de pointes and other ventricular dysrhythmias. We report the case of a 38-year-old firefighter with atrial tachycardia that was treated unsuccessfully according to Advanced Cardiac Life Support guidelines with IV adenosine. Subsequently, 2 g of magnesium sulfate was administered intravenously over 5 minutes with resulting conversion of the patients' supraventricular tachycardia to normal sinus rhythm, with complete resolution of symptoms.