Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter

NCT05445297 | Completed Phase 4

• 1 other identifier: JCBY-2021-0007-275
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

atrial fibrillation and flutter; paroxysmal atrial fibrillation and flutter; cardioversion AF; Amiodarone; Refralon; Niferidil; new antiarrhythmic drug; new Russian antiarrhythmic drug refralon

Outcome Measures

Primary Outcomes (10)

• Restoration of sinus rhythm

  Restoration of SR within 1 hour from the start of drug administration (refralon/amiodarone).

  1 hour

• Restoration of sinus rhythm

  Restoration of SR within 24 hour from the start of drug administration (refralon/amiodarone).

  24 hours

• Number of patients who recovered sinus rhythm after the minimum dose of refralon.

  Number of patients who recovered SR when using refralon at a dose of 5 µg/kg.

  24 hours

• Sinus rhythm recovery time

  The time elapsed from the start of drug administration to recovery of SR

  24 hours

• Recurrent AF/AFL after successful cardioversion

  Absence of sustained (more than 30 seconds) recurrences of AF/AFL within 24 hours after successful cardioversion;

  24 hours

• Ventricular arrhythmogenic effect

  Registration of sustained and nonsustained (3 or more QRS) ventricular tachycardia or ventricular fibrillation after administration of drug (refralon/amiodarone)

  24 hours

• Increased QT interval (more than 500 ms)

  The number of patients who have an increase in the QT interval (more than 500 ms) and the time during which the duration of the QT interval exceeded 500 ms.

  24 hours

• Bradyarrhythmias (pauses and bradycardia)

  Decrease in heart rate to less than 50bpm after administration of drug (refralon/amiodarone) during AF or after restoration of SR - the minimum heart rate, the duration of the maximum recorded pause and the time during which the heart rate was less than 50bpm will be recorded

  24 hours

• Arterial hypotension

  Decrease in blood pressure by more than 20 mm Hg from the initial value(if asymptomatic) after administration of drug (refralon/amiodarone) or by more than 10 mm Hg (if symptomatic)

  24 hours

• Any clinical manifestations

  The appearance of any clinical manifestations after administration of drug (refralon/amiodarone) that are interpreted by the doctors of the intensive care unit as a worsening of patient's clinical status.

  24 hours

Study Arms (2)

Amiodarone group

OTHER

Drug: Pharmacological cardioversion with Amiodarone

Refralon group

OTHER

Drug: Pharmacological cardioversion with Refralon

Interventions

Pharmacological cardioversion with Amiodarone DRUG

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.

Also known as: Amiodarone

Amiodarone group

Pharmacological cardioversion with Refralon DRUG

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.

Also known as: Refralon

Refralon group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paroxysmal form of AF/AFL;
• Indications for SR recovery

You may not qualify if:

• Arrhythmogenic effect of refralon, amiodarone and other antiarrhythmic drugs in history;
• Chronic kidney disease with a decrease in glomerular filtration rate less than 30 ml / min / 1.73 m2;
• Chronic heart failure (functional class IV);
• Atrioventricular blockade of 2-3 degrees (with the exception of patients with an implanted pacemaker);
• Dysfunction of the sinoatrial node (with the exception of patients with an implanted pacemaker);
• Bradysystolic atrial fibrillation (heart rate \<50 beats/min);
• Duration of the QT interval \>440 ms;
• Hemodynamic instability requiring emergency cardioversion;
• Contraindications to anticoagulant therapy;
• Thyrotoxicosis or decompensated hypothyroidism;
• Uncorrected electrolyte disturbances at the time of cardioversion (potassium level less than 3.5 mmol/l);
• Pregnancy and breastfeeding period.

Sponsors & Collaborators

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

Study Sites (1)

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, 121552, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 6, 2022
• Study Start: January 26, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)