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临床试验/NCT05084495
NCT05084495已完成不适用

Can Global Peak Longitudinal Strain Measurements in Combination With Non-invasive ECG Parameters Predict the Success or Failure of Flecainide Treatment for Atrial Fibrillation Patients?

Lund University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Arrythmia free health status

研究概览

简要总结

This prospective observational study will include patients with atrial fibrillation that has indication for treatement with flecainide. Included patients are followed during a 12 month period. During the follow-up period they will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected. These data will be analysed in relation to outcome parameters as: maintaining a normal sinus rhythm (arrythmia free health status), number of AF-free months, chances of successful electrical cardioversion, frequency of side effects, risk of pro-arrhythmias and mortality. The importance of these two analyses is to improve the use of flecainide. Hence, today patients with low benefit compared to risk of adverse events are inappropriately treated with flecainide with the "trial and error" approach currently used. On the other hand flecainide is currently underutilized, and patients denied the treatment that could improve their quality of life, prognosis and reduce their risk of cardiovascular adverse events. By investigating novel and promising parameters there is the potential of a better prediction of initiating safe and accurate anti-arrhythmic therapy for patients with atrial fibrillation.

详细描述

Study synopsis for the Tambocor Prospective study

Inclusion: Patients with atrial fibrillation that admitted to the ward for prior to start of flecainide initiation.

Ethics: Informed Concent prior to inclusion.

Follow up after baseline: 4 visits during 12 month.

End points : Side effects that lead to discontinuation of flecainide. Persistent AF that lead to discontinuation of flecainide.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • All patients with written informed consent who are eligible for flecainide treatment for atrial fibrillation.
  • The patients must be followed at the Skånes hospitals northwest and Skånes university hospitals.
  • Age >18 years

排除标准

  • Flecainide treatment with other indication than atrial fibrillation (including atrial flutter).
  • No secure date for treatment start.
  • Age <18 years

结局指标

主要结局

Arrythmia free health status

时间窗: During the 12 month follow up

Can we predict who will maintain a normal sinus rhythm prior to initiation of flecainide? treatment start

次要结局

  • Frequency of side effects(During the 12 month follow up)
  • Number of AF-free months(During the 12 month follow up)
  • Risk of pro-arrhythmias(During the 12 month follow up)
  • Mortality(During the 12 month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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