Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial

NCT01597557 | Completed Results DMC

• 1 other identifier: MED7441011B
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Electrical Cardioversion; Magnesium Sulfate

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm

  Successful cardioversion involves conversion of atrial fibrillation to sinus rhythm and maintenance of sinus rhythm for one hour

  One hour after cardioversion

Secondary Outcomes (2)

• Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm

  One hour

• Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo

  30 minutes

Study Arms (2)

Magnesium Sulfate

ACTIVE COMPARATOR

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

Drug: Magnesium Sulfate

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Magnesium Sulfate DRUG

2 grams intravenous drip over 30 minutes

Magnesium Sulfate

Placebo OTHER

Normal Saline 50 ml intravenous drip over 30 minutes

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (1)

• 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.

  PMID: 27586232 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

Very few patients in paroxysmal AF, majority failed earlier rhythm control strategies making the study population a resistant population to treat, only one dose of Mg infusion was tested and the monitoring period was only 1 hour post cardioversion

Results Point of Contact

• Title: Dr. Anne Curtis
• Organization: University at Buffalo

abcurtis@buffalo.edu

716-859-4828

Study Officials

• Anne B Curtis, MD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

• Bharath Rajagopalan, MBBS

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

• Anne B Curtis, MD

  State University of New York at Buffalo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 14, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-09

Locations

US (1)