Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Electrical Cardioversion, Magnesium Sulfate
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
Interventions
DRUGMagnesium Sulfate
2 grams intravenous drip over 30 minutes
OTHERPlacebo
Normal Saline 50 ml intravenous drip over 30 minutes
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm | One hour after cardioversion | Successful cardioversion involves conversion of atrial fibrillation to sinus rhythm and maintenance of sinus rhythm for one hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Severe hypotensive episode with a Systolic BP \< 90mm hg with \> 20 mm Hg drop after infusion of the study drug or placebo |
Countries
United States
Participant flow
Pre-assignment details
Some patients enrolled in the study and received the study drug but did not undergo the cardioversion procedure due to various reasons
Participants by arm
| Arm | Count |
|---|---|
| Magnesium Sulfate Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure
Magnesium Sulfate: 2 grams intravenous drip over 30 minutes | 132 |
| Placebo Patients in this arm receive normal saline drip intravenously before the cardioversion procedure
Placebo: Normal Saline 50 ml intravenous drip over 30 minutes | 129 |
| Total | 261 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not undergo cardioversion procedure | 4 | 3 |
Baseline characteristics
| Characteristic | Magnesium Sulfate | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 10.4 | 65.6 years STANDARD_DEVIATION 11.9 | 65.5 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 132 participants | 129 participants | 261 participants |
| Sex: Female, Male Female | 43 Participants | 38 Participants | 81 Participants |
| Sex: Female, Male Male | 89 Participants | 91 Participants | 180 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 132 | 0 / 129 |
| serious Total, serious adverse events | 0 / 132 | 0 / 129 |
Outcome results
Primary
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
Time frame: One hour after cardioversion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Magnesium Sulfate | Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm | 114 Participants |
| Placebo | Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm | 111 Participants |
Secondary
Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo
Severe hypotensive episode with a Systolic BP \< 90mm hg with \> 20 mm Hg drop after infusion of the study drug or placebo
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Magnesium Sulfate | Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo | 0 Participants |
| Placebo | Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo | 0 Participants |
Secondary
Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm
Time frame: One hour
Population: Some patients enrolled in the study and received the study drug but did not undergo the cardioversion procedure per protocol and were excluded in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Sulfate | Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm | 123.3 Joules | Standard Deviation 55.5 |
| Placebo | Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm | 129.5 Joules | Standard Deviation 52.6 |