Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- maintenance of sinus rhythm at one year post DC Cardioversion
研究概览
简要总结
Persistent Atrial Fibrillation (AF) is a common and distressing cardiac arrhythmia and accounts for 1% of the healthcare budget in the UK and it's prevalence is rising. Symptoms of atrial fibrillation include palpitations, chest pain , shortness of breath and fatigue, with quality of life measures reduced for patients with persistent AF, increased stroke risk and increased all cause mortality rates. DC Cardioversion is used to restore normal sinus rhythm in patients with persistent AF. It has a high success rate but reoccurence of AF is common. The use of anti arrhythmic drugs (AADs) can augment the number of patients remaining in sinus rhythm at one year, with amiodarone currently the most superior. Unfortunately it can have serious side affects. Dronedarone is a related drug designed specifically to minimise the most serious side affects and is no approved and used prominently in the management of non permanent AF. However it has not yet been studied in a post DC Cardioversion population.
Patients in persistent AF who are referred for elective DC Cardioversionwill be randomised to receive either Amiodarone or Dronedarone to compare the ability to help maintain sinu rhythm post cardioverion in one NHS hospital. Patients will be followed up for a year post cardioversion to see if they stay in sinus rhythm.
Ho: there will be no difference in maintenance of sinus rhythm with the use of amiodarone or dronedarone
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
- •• Patients with persAF requiring dc cardioversion.
- •Patients must be over 18 years old.
- •Patients give informed consent form prior to participating in this study.
- •Patients must be on warfarin for at least 4 weeks or a transoesphageal ECHO must be performed at the time of dc cardioversion.
排除标准
- •• Patient is suffering with unstable angina in last 1 week.
- •Patient has had a myocardial infarction within last 2 months.
- •Patient is expecting or has had major cardiac surgery within last 2 months.
- •Patient is participating in a conflicting study.
- •Patient is mentally incapacitated and cannot consent or comply with follow-up.
- •Patient has NYHA class III/ IV heart failure.
- •Pregnancy.
- •Patient suffers with other cardiac rhythm disorders.
- •Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).
- •GFR<30mls/min.
- •Patients has a contraindication to amiodarone or dronedarone
研究组 & 干预措施
Amiodarone
this group will be given Amiodarone to maintain sinus rhythm powst cardioversion.
干预措施: amiodarone (Drug)
Dronedarone
this group will be given dronedarone to maintain sinus rhythm post DC cardioversion
干预措施: Dronedarone (Drug)
结局指标
主要结局
maintenance of sinus rhythm at one year post DC Cardioversion
时间窗: 1 year
次要结局
- tolerability of amiodarone compared to dronedarone(1 year)
- measures of quality of life and symptoms in amiodarone compared to dronedarone(1 year)