Clinical trial NCT05445297: Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter
Official title: Prospective Randomized Study Comparing the Efficacy and Safety of Refralon and Amiodarone in Cardioversion in Patients With Paroxysmal Atrial Fibrillation and Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Sponsor class: OTHER_GOV
First posted: 2022-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Atrial fibrillation (AF) and flutter (AFL) are the most common types of arrhythmia in clinical practice. Both electrical and medical cardioversion can be used to restore sinus rhythm. Currently, the most studied and commonly used drug for pharmacological cardioversion of paroxysms of AF/AFL is amiodarone, which belongs to class III antiarrhythmic drugs. The highest recovery rates of sinus rhythm (SR) (\>90%) are achieved with intravenous administration of amiodarone at a dose of more than 1500 mg / day or up to a maximum of 3000 mg / day. However, most commonly, amiodarone is used at a standard dose of 5 mg/kg body weight, with an efficacy of 34-69%. In 2014, a new Russian class III antiarrhythmic drug, Refralon, was registered. In 2020, the drug was included in the National Clinical Guidelines "Atrial Fibrillation and Flutter", approved by the Ministry of Health of the Russian Federation. When using refralon in doses from 10 to 30 μg/kg, SR recovery was noted in 91.6% of patients with persistent AF/AFL in 50% of patients SR restored within 15 minutes from the start of the drug administration.

Randomized trials comparing the efficacy and safety of refralon with other antiarrhythmic drugs have not been conducted. It is extremely important to directly compare the efficacy and safety of these two drugs in patients with paroxysmal AF in a prospective randomized study.

Eligibility criteria: Inclusion Criteria:

1. Paroxysmal form of AF/AFL;
2. Indications for SR recovery

Exclusion Criteria:

1. Arrhythmogenic effect of refralon, amiodarone and other antiarrhythmic drugs 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. Atrioventricular blockade of 2-3 degrees (with the exception of patients with an implanted pacemaker);
5. Dysfunction of the sinoatrial node (with the exception of patients with an implanted pacemaker);
6. Bradysystolic atrial fibrillation (heart rate \<50 beats/min);
7. Duration of the QT interval \>440 ms;
8. Hemodynamic instability requiring emergency cardioversion;
9. Contraindications to anticoagulant therapy;
10. Thyrotoxicosis or decompensated hypothyroidism;
11. Uncorrected electrolyte disturbances at the time of cardioversion (potassium level less than 3.5 mmol/l);
12. Pregnancy and breastfeeding period.

Primary outcomes:
measure: Restoration of sinus rhythm
timeFrame: 1 hour
measure: Restoration of sinus rhythm
timeFrame: 24 hours
measure: Number of patients who recovered sinus rhythm after the minimum dose of refralon.
timeFrame: 24 hours
measure: Sinus rhythm recovery time
timeFrame: 24 hours
measure: Recurrent AF/AFL after successful cardioversion
timeFrame: 24 hours
measure: Ventricular arrhythmogenic effect
timeFrame: 24 hours
measure: Increased QT interval (more than 500 ms)
timeFrame: 24 hours
measure: Bradyarrhythmias (pauses and bradycardia)
timeFrame: 24 hours
measure: Arterial hypotension
timeFrame: 24 hours
measure: Any clinical manifestations
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: 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
Study officials:
References: