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临床试验/NCT00845780
NCT00845780已完成4 期

Withdrawal of Amiodarone Treatment Versus Continuation in Successfully Treated Patients With Persistent Atrial Fibrillation. A Randomized Study.

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2000年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
37
试验地点
1
主要终点
occurrence of late relapse of persistent atrial fibrillation

研究概览

简要总结

Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of persistent atrial fibrillation. It can however cause many adverse events, both cardiac and non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult especially because of high recurrence rates during the first month after cardioversion. Duration of atrial fibrillation, type of underlying disease, left ventricular function, left atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial fibrillation may be related to a highly arrhythmogenic period due to recovery from electrical remodelling. Late recurrences may be related to other triggers than recovery from electrical remodelling. In this study the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of late relapses of persistent atrial fibrillation. Furthermore, the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of amiodarone related adverse events as well as adverse events related to atrial fibrillation or underlying heart disease. The investigators also want to investigate which patients characteristics are and potential triggers have a prognostic value in the occurence of late relapses after amiodarone withdrawal.

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

入选标准

  • history of persistent atrial fibrillation, necessitating at least one electrical cardioversion
  • presence of sinus rhythm during the last 6 months, while on amiodarone treatment without adverse events related to amiodarone
  • clinically stable
  • age > 18 years
  • written informed consent

排除标准

  • sinus rhythm maintenance is preferable (because of atrial fibrillation related morbidity or any other reason)
  • symptomatic heart failure NYHA III or IV
  • unstable angina pectoris
  • hemodynamically significant valvular disease
  • concomitant treatment with other class I or III antiarrhythmic drug
  • PCI,CABG, other cardiac surgery or major non-cardiac surgery within the last three months
  • recent myocardial infarction (< 3 months)
  • presence of any disease that is likely to shorten life expectancy to < 1 year

研究组 & 干预措施

withdrawal amiodarone

Experimental

withdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy

干预措施: withdrawal or continuation of amiodarone therapy (Drug)

continuation amiodarone

Active Comparator

continuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy

干预措施: withdrawal or continuation of amiodarone therapy (Drug)

结局指标

主要结局

occurrence of late relapse of persistent atrial fibrillation

时间窗: 2 years

次要结局

  • difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies(2 years)

研究者

申办方类型
Other

研究点 (1)

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