Magnesium Sulfate for Atrial Fibrillation Prevention

(ATOMIC Trial)

Recruiting at 3 trial locations

Overseen By Miranda Hunt

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dr. Stephanie Sibley

Must not be taking: Parenteral magnesium

Disqualifiers: Atrial fibrillation, Cardiac surgery, Dialysis, others

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: Unknown

Duration: 5 days

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether magnesium sulfate can prevent atrial fibrillation, an irregular heart rhythm, in critically ill ICU patients. Participants will receive either magnesium sulfate or a placebo to determine if magnesium reduces the risk of this heart issue. The trial seeks individuals in intensive care who are on a ventilator or require special heart or lung support. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Magnesium Sulfate?

Research has shown that patients usually tolerate magnesium sulfate well. It can help manage and prevent certain heart issues, such as abnormal heart rhythms, especially after heart surgery. For example, one study found that patients who received magnesium had a lower heart rate within 24 hours of experiencing atrial fibrillation, a type of irregular heartbeat. This suggests it might help stabilize heart rhythms.

Regarding safety, hospitals already use magnesium sulfate for various conditions, indicating it is generally safe. Some studies also suggest that low magnesium levels might increase the risk of heart rhythm problems, so taking magnesium might be helpful.

Overall, while magnesium sulfate seems safe to use, individual reactions can vary. Participants in any trial should discuss possible side effects and benefits with their healthcare providers. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for atrial fibrillation, which typically include medications like beta-blockers, calcium channel blockers, or anticoagulants, magnesium sulfate is being explored for its unique properties in stabilizing heart rhythms. Researchers are excited about magnesium sulfate because it offers a different mechanism of action, potentially aiding in the prevention of atrial fibrillation by addressing electrolyte imbalances that can contribute to irregular heartbeats. Additionally, magnesium sulfate is delivered intravenously, which might allow for rapid intervention and prevention right in the hospital setting, offering a new approach to managing this common cardiac condition.

What evidence suggests that magnesium sulfate might be an effective treatment for atrial fibrillation?

In this trial, participants will receive either Magnesium Sulfate or a placebo to evaluate its effectiveness in preventing atrial fibrillation. Research has shown that magnesium sulfate can help prevent atrial fibrillation, a condition where the heart beats irregularly. Studies have found that patients who received magnesium had a lower heart rate 24 hours after atrial fibrillation began. Another study found that continuous magnesium administration helped prevent irregular heartbeats after heart surgery. Magnesium works by correcting low magnesium levels, which can reduce the risk of this condition. However, some research suggests that magnesium did not significantly lower the chance of new atrial fibrillation compared to a placebo. Overall, magnesium is already known to help with some heart rhythm issues. ^{1 2 3 4 5}

Who Is on the Research Team?

Stephanie Sibley, MD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for adults over 18 in critical care needing breathing support or medication for shock. They must be receiving heart monitoring and expected to survive more than 24 hours. Pregnant women, those with current or past atrial fibrillation, patients post-cardiac surgery, on dialysis, or needing magnesium therapy cannot join.

Inclusion Criteria

I am in critical care needing breathing support or medication for shock.

I am under continuous heart monitoring.

Exclusion Criteria

I was admitted to the ICU more than 12 hours ago.

You are not expected to live more than 24 hours, or you are receiving palliative care.

I have ongoing or occasional atrial fibrillation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either magnesium sulfate or placebo intravenously for a total of 10 doses

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Long-term follow-up

Participants are monitored for functional outcomes such as death after discharge

365 days

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Sulfate
• Placebo

Trial Overview

The study tests if magnesium sulfate can prevent new-onset atrial fibrillation in critically ill ICU patients compared to a placebo. It's a double-blind pilot trial meaning neither the participants nor the researchers know who receives the real treatment.

How Is the Trial Designed?

Group I: Magnesium Sulfate Experimental Treatment 1 Intervention

4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses

Group II: 0.9% NaCl Placebo Group 1 Intervention

100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses

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?

Dr. Stephanie Sibley

Lead Sponsor

Trials

1

Recruited

140+

Dr. Stephanie Sibley

Lead Sponsor

Trials

1

Recruited

140+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Southeastern Ontario Academic Medical Organization (SEAMO)

Collaborator

Trials

1

Recruited

140+

Published Research Related to This Trial

Intravenous magnesium sulfate was successfully used to treat tachyarrhythmias in four patients, demonstrating rapid efficacy and no adverse reactions, particularly in cases resistant to other treatments.

The treatment was effective for different types of tachyarrhythmias, including supraventricular tachycardia and torsade de pointes, suggesting that magnesium sulfate could be a valuable option for patients with magnesium depletion or resistant arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic effectiveness of intravenous magnesium sulfate in tachyarrhythmia. Apropos of 4 clinical cases]. Rabaçal, C., Pereira, D., Carvalho, E., et al.[2006]

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 234 patients undergoing coronary artery bypass grafting (CABG), those who received intravenous magnesium sulfate had a significantly lower incidence of postoperative atrial fibrillation (AF) compared to those who did not receive the treatment (p = 0.038).

While magnesium sulfate reduced the occurrence of AF after surgery, it did not affect the number of patients discharged with AF, and patients who experienced AF had a higher likelihood of longer hospital stays (p = 0.036).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium sulfate for prevention of postoperative atrial fibrillation in patients undergoing coronary artery bypass grafting. Brackbill, ML., Moberg, L.[2019]

In a study of 167 coronary artery bypass patients, adding magnesium sulfate to propranolol did not significantly reduce the incidence of postoperative atrial fibrillation compared to propranolol alone, with rates of 22.4% and 19.5% respectively.

The combination of magnesium and propranolol led to more cases of postoperative hypotension, which complicated treatment and did not provide a clear benefit in preventing atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combination of propranolol and magnesium does not prevent postoperative atrial fibrillation. Solomon, AJ., Berger, AK., Trivedi, KK., 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]

Intravenous magnesium sulfate (MgSO4) significantly reduced the ventricular rate in patients with rapid atrial fibrillation, showing a notable decrease at 15, 30, and 60 minutes after administration.

The effectiveness of MgSO4 did not vary between magnesium deficient and nondeficient patients, indicating that magnesium levels do not influence the response to this treatment in the context of rapid atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium efficacy in magnesium deficient and nondeficient patients with rapid ventricular response atrial fibrillation. Eray, O., Akça, S., Pekdemir, M., et al.[2020]

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]

In a study of 88 patients undergoing elective coronary artery bypass grafting (CABG), magnesium sulfate (MgSO4) was found to be safe and effective in reducing the incidence of atrial fibrillation (AF) post-surgery, with no significant complications related to its use.

Both high (10 gm) and low (5 gm) doses of MgSO4 showed similar effectiveness in preventing AF, suggesting that the lower dose is sufficient and may help avoid potential adverse effects associated with higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium Sulfate Reduces Incidence of Atrial Fibrillation after Coronary Arterial Bypass Surgery: What Is the Proper Dose? A Randomized Trial. Taksaudom, N., Cheewinmethasiri, J., Chittawatanarat, K., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8691303/

The Role of Magnesium in the Management of Atrial ...

Patients that received magnesium had a lower mean heart rate after 24 hours of the onset of the atrial fibrillation with RVR episode compared to the patients ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12324752/

The Effect of Continuous Magnesium Infusion to Prevent ...

Conclusion: Postoperative continuous magnesium infusion after a bolus was effective in preventing POAF in patients undergoing OP-CABG by ...

3.

academic.oup.com

academic.oup.com/ehjcvp/article/3/2/108/2669829

Treating arrhythmias with adjunctive magnesium: identifying ...

Prevention of post-operative atrial fibrillation​​ Thus, prophylactic use of magnesium has the potential to correct these deficiencies and reduce POAF risk.

4.

researchgate.net

researchgate.net/publication/375023695_Magnesium_prophylaxis_of_new-onset_atrial_fibrillation_A_systematic_review_and_meta-analysis

(PDF) Magnesium prophylaxis of new-onset atrial fibrillation

Administration of magnesium did not significantly reduce the incidence of NOAF compared to placebo (OR 0.72, [95% CI 0.48 to 1.09]). Conclusion ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02928315

The Effect of Magnesium Therapy to Prevent Post- ...

It has been shown that magnesium suppresses arrhythmias after acute myocardial infarction, and there are studies confirming correlation between ...