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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiodarone group | Other |
| |
| Refralon group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacological cardioversion with Amiodarone | Drug | Patients in this group will receive intravenous amiodarone according to the following scheme:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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|
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| Pharmacological cardioversion with Refralon | Drug | Patients in this group will receive intravenous refralon according to the following scheme:
|
|
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| 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 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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