Clinical Trial to Evaluate the Antiarrhythmic Effects of Acupuncture for Drug Resistant Persistent Atrial Fibrillation: Randomized, Participant and Assessor Blinded, Sham-controlled, Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recurrence of atrial fibrillation evaluated on serial electrocardiography and 48 hour holter monitoring after sinus conversion by electrical cardioversion
研究概览
简要总结
The aim of this trial is to evaluate the effect of acupuncture on prevention of atrial fibrillation (AF) recurrence after electrical cardioversion (EC) for persistent AF patients resistant to the antiarrhythmic drugs (AADs).
详细描述
This is a multicenter, prospective, participant and assessor blinded, randomized, sham-controlled clinical trial with 2 parallel arms. To evaluate the efficacy and safety of acupuncture, a total of 80 persistent AF participants will be recruited and randomly assigned to active acupuncture and sham acupuncture group. Both group commonly take antiarrhythmic medication during study period. These patients who are resistant to drug therapy will get a electrical cardioversion. After cardioversion, the recurrence rate and duration of atrial fibrillation free time will be evaluated.
This trial consists of 2 weeks of observation and medical therapy, 2 weeks of acupuncture intervention before EC, EC and acupuncture intervention, 7 weeks of additional intervention, and 5 weeks of follow-up. After randomization, participants receive 10 sessions of acupuncture treatments over 10 weeks. The outcome is assessed at 2, 4, 6, 8, and 16 week after randomization.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent AF lasting ≥ 7 days
- •Ages in 20-75 years
- •Resistant with antiarrhythmic drugs
- •Written informed consent
排除标准
- •Age below 20 years or above 75 years
- •Severe valvular heart disease
- •History of open heart surgery
- •History of treatment for myocardial infarction (MI) within recent 6 weeks
- •Patients under or requiring the administration of antiviral drugs
- •2nd degree atrioventricular block or more than two fascicular block
- •Severe pulmonary, liver, or renal disease
- •Previous acupuncture treatment for cardiovascular condition within 3 months
研究组 & 干预措施
Active Acupuncture + flecainide
The participants in this group receive verum acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
干预措施: Active Acupuncture (Procedure)
Active Acupuncture + flecainide
The participants in this group receive verum acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
干预措施: flecainide (Drug)
Sham acupuncture + flecainide
The participants in this group receive sham acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
干预措施: Sham acupuncture (Procedure)
Sham acupuncture + flecainide
The participants in this group receive sham acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
干预措施: flecainide (Drug)
结局指标
主要结局
Recurrence of atrial fibrillation evaluated on serial electrocardiography and 48 hour holter monitoring after sinus conversion by electrical cardioversion
时间窗: 3 months after electrical cardioversion
When patient feel symptoms such as palpitation and chest discomfort, the patients are recommended to visit hospital to check out the recurrence of atrial fibrillation.
次要结局
- Change of inflammation marker (hsCRP)(3 months after electrical cardioversion)
- Changes in function and volume of left atrium and left atrial appendage evaluated by echocardiography(3 months after electrical cardioversion)
- Number of Participants with Adverse Events (AEs)(Participants will be followed for the duration of this study, an expected average 14 weeks)
- the factor to make atrial fibrillation recur(3 months later after electrical cardioversion)
研究者
Weon Kim
Professor
Kyunghee University Medical Center