Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial

NCT ID: NCT01597557

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-02-28

Brief Summary

The proposed study is designed to evaluate the effect of an intravenous infusion of magnesium sulfate in facilitating successful cardioversion of atrial fibrillation and in decreasing the energy threshold (in J) required for successful cardioversion of atrial fibrillation into sinus rhythm.

Detailed Description

Patients with atrial fibrillation may suffer from disabling symptoms such as palpitations, shortness of breath or worsening heart failure. In such patients, it may be beneficial to convert their rhythm to sinus rhythm. Cardioversion can be achieved either pharmacologically or electrically. Pharmacological cardioversion is less successful acutely than electrical cardioversion and may be associated with complications such as prolongation of the QT interval and torsades de pointes (polymorphic ventricular tachycardia). Thus, cardioversion is most often accomplished electrically, using biphasic synchronized shocks of 75-200 Joules. Biphasic electrical cardioversion in atrial fibrillation has shown to be successful (i.e., converting to sinus rhythm) about 88% of the time, on average. The success rate appears to largely depend upon the duration of the arrhythmia and the presence and severity of structural heart disease.

In this study, we will evaluate the effect of intravenous magnesium sulfate on the success rate of electrical cardioversion, and also assess its effect in decreasing the energy levels needed for successful cardioversion. If the study is successful, we will have shown that a simple and inexpensive intervention can increase the success rate of electrical cardioversion, increasing the proportion of patients who can be restored to sinus rhythm. In addition, success with lower energy levels may improve the safety of cardioversion, as high energy levels are more likely to be associated with side effects

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Magnesium Sulfate

Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure

Group Type: ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type: DRUG

2 grams intravenous drip over 30 minutes

Placebo

Patients in this arm receive normal saline drip intravenously before the cardioversion procedure

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Normal Saline 50 ml intravenous drip over 30 minutes

Interventions

Magnesium Sulfate

2 grams intravenous drip over 30 minutes

Intervention Type: DRUG

Placebo

Normal Saline 50 ml intravenous drip over 30 minutes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient with new onset Atrial fibrillation less than 48 hours after onset undergoing electrical cardioversion.
• Patients with atrial fibrillation longer than 48 hours on warfarin with documented therapeutic INR levels >2 for at least 3 weeks prior to the cardioversion, or been on dabigatran for 3 weeks, or a transesophageal echocardiogram on the day of the procedure that excludes intracardiac thrombi, undergoing electrical cardioversion.

Exclusion Criteria

• Creatinine >2.0 mg/dl
• Potassium level less than 3.5 mmol/dl
• TSH < 0.5
• Magnesium levels >3.0 mg/dl
• Urgent need for cardioversion (e.g., hemodynamic instability, unstable angina, pulmonary edema)
• Patients with recent (less than 6 weeks) acute myocardial infarction
• Patients post-cardiac surgery
• Pregnant women
• Patients who are being treated with antiarrhythmic drugs who have received less than five doses of the drug. For amiodarone, patients who have received less than three weeks prior to cardioversion are excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Anne Curtis

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne B Curtis, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Bharath Rajagopalan, MBBS

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Anne B Curtis, MD

Role: STUDY_CHAIR

State University of New York at Buffalo

Locations

State University of New York at Buffalo

Buffalo, New York, United States

Countries

United States

References

Rajagopalan B, Shah Z, Narasimha D, Bhatia A, Kim CH, Switzer DF, Gudleski GH, Curtis AB. Efficacy of Intravenous Magnesium in Facilitating Cardioversion of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2016 Sep;9(9):e003968. doi: 10.1161/CIRCEP.116.003968.

Reference Type: DERIVED

PMID: 27586232 (View on PubMed)

Other Identifiers

MED7441011B

Identifier Type: -

Identifier Source: org_study_id