N/A
N=261
Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01597557 ↗Enrolled (actual)
261
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm — 114; 111 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnesium Sulfate (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm |
114; 111 | — |
| SECONDARY Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm |
123.3; 129.5 | — |
| SECONDARY Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo |
0; 0 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT01597557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.