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Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter

NCT05445297 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-27

No results posted yet for this study

Summary

Patients hospitalized with paroxysmal atrial fibrillation and flutter to restore sinus rhythm will be randomized into two groups: one will be cardioversion with refralon and the other with amiodarone

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.

Sponsors & Collaborators

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

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-26
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445297 on ClinicalTrials.gov