跳至主要内容
临床试验/NCT02958839
NCT02958839Unknown不适用

The Relationship Between Fibroblast Growth Factor 23 and the Recurrence of Atrial Fibrillation After Catheter Ablation: a Nested Case-Control Study

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Incidence of the recurrence of atrial fibrillation

研究概览

简要总结

To investigate whether fibroblast growth factor 23 can be used to predict recurrence after catheter ablation for atrial fibrillation and to provide an objective basis for the clinical selection of the optimal patients for catheter ablation.

详细描述

Atrial fibrillation, which can result in stroke and thromboembolism in an approximately 5-fold increased risk, has been a great burden to health care system with the aging of population. Catheter ablation is the most promising treatment of atrial fibrillation. However, the recurrence rates of AF after catheter ablation are high, ranging from 20%-60%. Therefore, non-invasive predictors for AF recurrence after catheter ablation is necessary to select the optimal patients for this procedure.

Fibroblast growth factor-23 (FGF-23) is a bone-derived hormone that plays a central role in phosphate homeostasis. Recent study showed that fibroblast growth factor 23 plays an important role in cardiac remodeling and is considered to be independently associated with the occurrence of atrial fibrillation. In this study, we are going to observe the relationship between the serum FGF-23 and the arrythmia recurrence after catheter ablation of AF.

This research is going to recruit 200 consecutive patients with a history of atrial fibrillation for 180-360 days who intend to undergo catheter ablation. The day before catheter ablation, serum FGF-23 level will be detected. Echocardiogram and left atrial CT scan will also be performed on the day before catheter ablation. All patients will be routinely follow up in the outpatient department by cardiologists every month for 1 year. If patients complain about palpitations, fatigue, or other symptoms related to arrhythmia, Holter monitoring will be performed. Patients will also be advised to see their doctor anytime they have these symptoms and to undergo a 12-lead ECG examination or 24-hour Holter monitoring. In asymptomatic patients, 24-hour Holter monitoring or 7-day cardiac event recording will be performed every three months after the procedure. The endpoint for follow-up is the recurrence of atrial fibrillation, which is considered to be any episode of AF/AFL/AT after a blank period of 3 months after the procedure of catheter ablation. Those who develop recurrence of AF during follow up will be assigned to recurrence group, and those who do not develop recurrence of AF during follow up will be assigned to non-recurrence group. Comparison of the serum FGF-23 level between the two groups will be carried out in order to investigate the relationship between serum FGF-23 level and the recurrence of AF.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have a history of atrial fibrillation for 180 to 360 days
  • Provide written informed consent, having understood the benefits and risks of participation in the trial

排除标准

  • Significant structural heart disease (including symptomatic coronary heart disease; prosthetic mitral or tricuspid valve; congenital heart disease where abnormality or its correction prohibits or increases the risk of ablation)
  • Atrial Fibrillation precipitated by other diseases (such as thyrotoxicosis)
  • Severe dysfunction of liver or kidney
  • Malignant tumor
  • Inability or refusal to provide written informed consent for the study

结局指标

主要结局

Incidence of the recurrence of atrial fibrillation

时间窗: after 3 months from the procedure of catheter ablation

The recurrence of atrial fibrillation is considered to be any episode of AF/AFL/AT after a blank period of 3 months after the procedure of catheter ablation

次要结局

  • CHA2DS2-VASc score(after 3 months from the procedure of catheter ablation)
  • Plasma fibroblast growth factor 23 levels(after 3 months from the procedure of catheter ablation)
  • Cardiac CT evaluation(after 3 months from the procedure of catheter ablation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhongkai Zhao

intern of cardiology

Peking University Third Hospital

研究点 (1)

Loading locations...

相似试验