Refralon in Patients With Recurrence Paroxysmal and Persistent Forms of Atrial Fibrillation Who Underwent Catheter Ablation

NCT05456204 | Completed

• 1 other identifier: JCBY-2021-0007-288
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

It is planned to evaluate the efficacy and safety of the class III antiarrhythmic drug refralon as a drug for pharmacological cardioversion in patients with recurrent atrial fibrillation (AF) and atrial flutter (AFL) after catheter ablation.

Conditions

Atrium; Fibrillation; Atrium; Flutter

Keywords

atrial fibrillation and flutter; paroxysmal and persistent atrial fibrillation and flutter; cardioversion AF; catheter radiofrequency ablation; Refralon; Niferidil; new antiarrhythmic drug; balloon cryoablation; reccurrence atrial fibrillation and flutter

Outcome Measures

Primary Outcomes (4)

• Restoration of sinus rhythm

  Restoration of SR within 24 hours from the moment of administration of the first dose of refraloRestoration of SR within 24 hours from the moment of administration of the first dose of refralon

  24 hour

• Preservation of SR

  Preservation of SR 24 hours after the first dose of refralon.

  24 hours

• Ventricular arrhythmogenic effect

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

  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

Secondary Outcomes (5)

• Restoration of sinus rhythm within 6 hours

  6 hours

• Number of patients recovering SR after minimal doses

  24 hours

• Reccurence after SR recovery

  24 hours

• Bradyarrhythmias (pauses and bradycardia)

  24 hours

• Pauses more than 5 seconds

  24 hours

Study Arms (1)

Refralone group

OTHER

Patients with recurrent AF/AFL after catheter interventions to restore SR will be cardioverted with refralon

Drug: Pharmacological cardioversion with Refralon

Interventions

Pharmacological cardioversion with Refralon DRUG

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: Refralone

Refralone group

Eligibility Criteria

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

You may qualify if:

• \. Patients with paroxysmal or persistent forms of AF/AFL and early (less than 90 days) or late (more than 90 days) arrhythmia recurrence after catheter radiofrequency ablation or balloon cryoablation of pulmonary veins.
• \. Indications for SR recovery. 4. Consent of the patient.

You may not qualify if:

• Arrhythmogenic effect of antiarrhythmic drugs III class 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);
• Acute coronary syndrome;
• Bronchial asthma of an uncontrolled course and / or severe respiratory failure.
• The need for the use of drugs that increase the duration of the QT interval drugs without the possibility of withdrawal
• 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; Atrial Flutter

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 13, 2022
• Study Start: February 15, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

RU (1)