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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate | Active Comparator | Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure |
|
| Placebo | Placebo Comparator | Patients in this arm receive normal saline drip intravenously before the cardioversion procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | 2 grams intravenous drip over 30 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Severe hypotensive episode with a Systolic BP < 90mm hg with > 20 mm Hg drop after infusion of the study drug or placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York at Buffalo | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27586232 | Derived | 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. |
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Some patients enrolled in the study and received the study drug but did not undergo the cardioversion procedure due to various reasons
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Patients in this arm receive normal saline drip intravenously before the cardioversion procedure Placebo: Normal Saline 50 ml intravenous drip over 30 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | One hour after cardioversion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Curtis | University at Buffalo | 716-859-4828 | abcurtis@buffalo.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Placebo |
| Other |
Normal Saline 50 ml intravenous drip over 30 minutes |
|
| 30 minutes |
Patients in this arm receive normal saline drip intravenously before the cardioversion procedure
Placebo: Normal Saline 50 ml intravenous drip over 30 minutes
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm | 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 | Posted | Mean | Standard Deviation | Joules | One hour |
|
|
|
| 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 | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| 0 |
| 132 |
| 0 |
| 132 |
| EG001 | Placebo | Patients in this arm receive normal saline drip intravenously before the cardioversion procedure Placebo: Normal Saline 50 ml intravenous drip over 30 minutes | 0 | 129 | 0 | 129 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |