Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 26, 2022

Primary Completion Date

June 30, 2023

Study Completion Date

June 30, 2023

Conditions
Atrial Fibrillation Paroxysmal
Interventions
DRUG

Pharmacological cardioversion with Amiodarone

"Patients in this group will receive intravenous amiodarone according to the following scheme:~1. administration of 5 mg/kg body weight of amiodarone diluted in 250 ml of 5% glucose solution intravenously for 20-60 minutes, depending on the tolerability of the drug.~2. if there is no effect (recovery of SR did not occur within 60 minutes from the start of the drug administration), continue the infusion of amiodarone intravenously at a dose of 100 mg/hour until a total dose of 1200 mg is reached."

DRUG

Pharmacological cardioversion with Refralon

"Patients in this group will receive intravenous refralon according to the following scheme:~1. the introduction of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight, diluted in 20 ml of saline intravenously for 2-3 minutes;~2. in the absence of effect (SR recovery did not occur), after 15 minutes, repeated intravenous administration of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight (total dose of the drug 10 μg / kg of body weight);~3. in the absence of effect (SR recovery did not occur), after 15 minutes, the next intravenous injection of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight (total dose of the drug 20 μg / kg of body weight);~4. in the absence of effect (recovery of SR did not occur), after 15 minutes, repeated intravenous administration of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight. Thus, the maximum total dose of the drug will be 30 μg/kg of body weight."

Trial Locations (1)

121552

Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADEMICIAN E.I.CHAZOV. of the Ministry of Health of the Russian Federation, Moscow

All Listed Sponsors
lead

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

OTHER_GOV