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

Atrium; Fibrillation Clinical Trial

Official title:

Efficacy and Safety of Refralon in Patients With Recurrent Atrial Fibrillation and Atrial Flutter After Catheter Ablation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456204
• Other study ID #: JCBY-2021-0007-288
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: July 2022
• Source: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Contact: Nikolay Yu Mironov, PhD
• Phone: 84954146619
• Email: nikmir.7ko[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Atrial fibrillation and atrial flutter are the most common arrhythmias among the adult population of the world, their share in the population is from 2 to 4% and continues to grow.

Modern highly effective methods of minimally invasive surgical treatment of these types of arrhythmia are currently catheter radiofrequency ablation and balloon cryoablation of the pulmonary veins. According to the CABANA study, catheter interventions reduce the risk of recurrent AF/AFL by 47%, significantly improving arrhythmia tolerance and improving the quality of life of patients.

An important problem is the recurrence of arrhythmia after the intervention, the frequency of recurrence of AF/AFL in the first 3 months after ablation (the so-called early recurrence) is 50-60%. In many patients, these recurrence are accompanied by severe clinical manifestations, which require pharmacological or electrical cardioversion.

In order to restore sinus rhythm, electrical cardioversion is most often used, the effectiveness of which is 90-92%.

An alternative to electrical cardioversion is pharmacological cardioversion, however, antiarrhythmic drugs used in wide clinical practice can restore sinus rhytm (SR) only in patients with recent AF paroxysms.

In 2014, a new Russian class III antiarrhythmic drug, Refralon, was registered. The effectiveness of the Refralon as a means of cardioversion in patients with persistent AF/AFL is 90%, in patients with paroxysmal AF/AFL - 95%.

At present, there is no information on the efficacy and safety of the use of refralon in patients with AF / AFL who underwent catheter ablation. The growing number of catheter ablation in the world dictates the to study new approaches to performing cardioversion in this cohort of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 30, 2024
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

2. 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.

3. Indications for SR recovery. 4. Consent of the patient.

Exclusion Criteria:

1. Arrhythmogenic effect of antiarrhythmic drugs III class in history;

2. Chronic kidney disease with a decrease in glomerular filtration rate less than 30 ml / min / 1.73 m2;

3. Chronic heart failure (functional class IV);

4. Acute coronary syndrome;

5. Bronchial asthma of an uncontrolled course and / or severe respiratory failure.

6. The need for the use of drugs that increase the duration of the QT interval drugs without the possibility of withdrawal

7. Atrioventricular blockade of 2-3 degrees (with the exception of patients with an implanted pacemaker);

8. Dysfunction of the sinoatrial node (with the exception of patients with an implanted pacemaker);

9. Bradysystolic atrial fibrillation (heart rate <50 beats/min);

10. Duration of the QT interval >440 ms;

11. Hemodynamic instability requiring emergency cardioversion;

12. Contraindications to anticoagulant therapy;

13. Thyrotoxicosis or decompensated hypothyroidism;

14. Uncorrected electrolyte disturbances at the time of cardioversion (potassium level less than 3.5 mmol/l);

15. Pregnancy and breastfeeding period.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrium; Fibrillation

Intervention

Drug:
• Pharmacological cardioversion with Refralon
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; 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); 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); 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.

Locations

Country	Name	City	State
Russian Federation	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

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Preservation of SR	Preservation of SR 24 hours after the first dose of refralon.	24 hours
Primary	Ventricular arrhythmogenic effect	Registration of sustained and nonsustained (3 or more QRS) ventricular tachycardia or ventricular fibrillation after administration of drug	24 hours
Primary	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	Restoration of sinus rhythm within 6 hours	Restoration of SR within 6 hours from the moment of administration of the first dose of refralon	6 hours
Secondary	Number of patients recovering SR after minimal doses	Number of patients who recovered SR after minimal doses of refralon (5-10 µg/kg)	24 hours
Secondary	Reccurence after SR recovery	Absence of sustained (lasting more than 30 seconds) recurrences of AF/AFL within 24 hours after successful recovery of SR with refralon	24 hours
Secondary	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
Secondary	Pauses more than 5 seconds	The presence of pauses for more than 5 seconds at the time of SR recovery or against the background of persistent AF/AT.	24 hours