Trial Outcomes & Findings for Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial (NCT NCT01597557)

NCT ID: NCT01597557

Last Updated: 2020-10-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 261 participants
• Primary outcome timeframe: One hour after cardioversion
• Results posted on: 2020-10-22

Participant Flow

Some patients enrolled in the study and received the study drug but did not undergo the cardioversion procedure due to various reasons

Participant milestones

Measure	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	Placebo Patients in this arm receive normal saline drip intravenously before the cardioversion procedure Placebo: Normal Saline 50 ml intravenous drip over 30 minutes
Overall Study STARTED	132	129
Overall Study COMPLETED	128	126
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	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	Placebo Patients in this arm receive normal saline drip intravenously before the cardioversion procedure Placebo: Normal Saline 50 ml intravenous drip over 30 minutes
Overall Study Did not undergo cardioversion procedure	4	3

Baseline Characteristics

Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial

Baseline characteristics by cohort

Measure	Magnesium Sulfate n=132 Participants 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	Placebo n=129 Participants Patients in this arm receive normal saline drip intravenously before the cardioversion procedure Placebo: Normal Saline 50 ml intravenous drip over 30 minutes	Total n=261 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 10.4 • n=5 Participants	65.6 years STANDARD_DEVIATION 11.9 • n=7 Participants	65.5 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	38 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	91 Participants n=7 Participants	180 Participants n=5 Participants
Region of Enrollment United States	132 participants n=5 Participants	129 participants n=7 Participants	261 participants n=5 Participants

PRIMARY outcome

Timeframe: One hour after cardioversion

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

Outcome measures

Measure	Magnesium Sulfate n=132 Participants 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	Placebo n=129 Participants Patients in this arm receive normal saline drip intravenously before the cardioversion procedure Placebo: Normal Saline 50 ml intravenous drip over 30 minutes
Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm	114 Participants	111 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Magnesium Sulfate n=130 Participants 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	Placebo n=126 Participants Patients in this arm receive normal saline drip intravenously before the cardioversion procedure Placebo: Normal Saline 50 ml intravenous drip over 30 minutes
Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm	123.3 Joules Standard Deviation 55.5	129.5 Joules Standard Deviation 52.6

SECONDARY outcome

Timeframe: 30 minutes

Severe hypotensive episode with a Systolic BP < 90mm hg with > 20 mm Hg drop after infusion of the study drug or placebo

Outcome measures

Measure	Magnesium Sulfate n=132 Participants 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	Placebo n=129 Participants Patients in this arm receive normal saline drip intravenously before the cardioversion procedure Placebo: Normal Saline 50 ml intravenous drip over 30 minutes
Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo	0 Participants	0 Participants

Adverse Events

Magnesium Sulfate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anne Curtis

University at Buffalo

Phone: 716-859-4828

Email: abcurtis@buffalo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place