Prospective Randomized Study Comparing the Efficacy and Safety of Refralon and Amiodarone in Cardioversion in Patients With Paroxysmal Atrial Fibrillation and Flutter
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sinus rhythm recovery time
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal form of AF/AFL;
- •Indications for SR recovery
排除标准
- •Arrhythmogenic effect of refralon, amiodarone and other antiarrhythmic drugs 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);
- •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.
研究组 & 干预措施
Amiodarone group
干预措施: Pharmacological cardioversion with Amiodarone (Drug)
Refralon group
干预措施: Pharmacological cardioversion with Refralon (Drug)
结局指标
主要结局
Sinus rhythm recovery time
时间窗: 24 hours
The time elapsed from the start of drug administration to recovery of SR
Ventricular arrhythmogenic effect
时间窗: 24 hours
Registration of sustained and nonsustained (3 or more QRS) ventricular tachycardia or ventricular fibrillation after administration of drug (refralon/amiodarone)
Bradyarrhythmias (pauses and bradycardia)
时间窗: 24 hours
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
Arterial hypotension
时间窗: 24 hours
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)
Any clinical manifestations
时间窗: 24 hours
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.
Increased QT interval (more than 500 ms)
时间窗: 24 hours
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.
Number of patients who recovered sinus rhythm after the minimum dose of refralon.
时间窗: 24 hours
Number of patients who recovered SR when using refralon at a dose of 5 µg/kg.
Restoration of sinus rhythm
时间窗: 24 hours
Restoration of SR within 24 hour from the start of drug administration (refralon/amiodarone).
Recurrent AF/AFL after successful cardioversion
时间窗: 24 hours
Absence of sustained (more than 30 seconds) recurrences of AF/AFL within 24 hours after successful cardioversion;
次要结局
未报告次要终点