Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Average AF burden in minutes per day
研究概览
简要总结
The current evidences indicate that ~30% patients with sick sinus syndrome(SSS) would develop persistent atrial fibrillation (AF) after a long term pacing therapy. However, the accurate influence of antiarrhythmic drugs on the AF is still not well defined. The purpose of the study is to assess the therapeutic effects of various antiarrhythmic drugs (Amiodarone, Sotalol and Propafenone) on the long term management of AF in SSS patients with AF, including the reduced AF burden (duration and episodes) and persistent AF free survival rate. All patients will be followed up for 12 months.
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
- None
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
- •at least 18 years old
- •sick sinus syndrome with pacemaker Class I or Class IIa indication
- •has a pacemaker which can provide the daily AF burden monitor record for at least 28 days
- •has at AF record in the past 6 months, the valid AF record includes any of
- •at least one 30 seconds AF holter record
- •at least one 15 seconds 12-ECG record
- •at least 5 minutes long AF episodes record from pacemakers
- •able and willing to give informed consent
排除标准
- •will have cardiac surgery in the next 6 month or in the waiting list of heart transplantation
- •NYHA Class III or IV
- •LVEF <50%
- •Reversible AF, such as AF caused by hyperthyroidism or severe postoperative atrial fibrillation
- •Persistence AF
- •Expected life expectancy less than 1 year
- •Planned to be pregnant or be in the feeding period in the next year
- •Non-stable, decompensated heart failure
- •Allergy to Amiodarone, Propafenone or Sotalol
- •Clear liver damage ( ALT and/or AST > 2*normal limit)
- •Patients with cardiogenic shock history
- •Be in the treatment of Amiodarone for more than 3 months or less than 3 months with Amiodarone wash out period less than 30 days
- •Coronary artery disease (CHD), cardiomyopathy, severe valvular heart disease, severe obstructive pulmonary disease (COPD), long QT syndrome
研究组 & 干预措施
Amiodarone
Patient will take Amiodarone orally
干预措施: Amiodarone (Drug)
Sotalol
Patients will take sotalol orally
干预措施: Sotalol (Drug)
Propafenone
Patients will take propafenone orally
干预措施: Propafenone (Drug)
结局指标
主要结局
Average AF burden in minutes per day
时间窗: monthly up to 12 months
Long term usages of test drug reduce AF burden, including the number and accumulated total time of AF per day.
Persistent AF free survival rate
时间窗: monthly up to12 months
Long term usages of test drugs reduce the occurence of the persistent AF ( the persistent AF survival rate)。
次要结局
- Left ventricular function(0months, 6months and 12 months)
- SF-36 health survey(0 months, 6 months and 12 months)
- comorbidity and mortality(6 months and 12 months)
研究者
Yi-Gang Li
Chief Physician
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine