Refralon Versus Amiodarone for Cardioversion of Paroxysmal Fibrillation and Atrial Flutter

• Status: Recruiting
• Trial end date: 2024-03-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Treatments: Amiodarone

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.