Clinical trial NCT01597557: Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial
Official title: Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Electrical Cardioversion
Magnesium Sulfate
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2012-05-14
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm
timeFrame: One hour after cardioversion
Secondary outcomes:
measure: Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm
timeFrame: One hour
measure: Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University of New York at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Anne B Curtis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York at Buffalo
name: Bharath Rajagopalan, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York at Buffalo
name: Anne B Curtis, MD
role: STUDY_CHAIR
References:
citation: 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.