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临床试验/NCT02380365
NCT02380365Unknown不适用

QT-Prolongation in Lung Transplantation

Hannover Medical School1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
720
试验地点
1
主要终点
prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation

研究概览

简要总结

Experimental intervention: electrocardiography. Control intervention: none

Duration of intervention per patient/subject:

5 min, observation 6 months

Key inclusion criteria:

  • outpatients after lung transplantation (single, double or combined)
  • outpatients on the wait list for lung transplantation

Key exclusion criteria:

• no informed consent

详细描述

Primary endpoint:

• prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation

Key secondary endpoint(s):

  • prevalence of any QTc-interval prolongation (>440 msec ) after lung transplantation
  • prevalence of PQ prolongation (200 msec sec or above) after lung transplantation
  • prevalence of QRS prolongation (120 msec or above) after lung transplantation
  • prevalence of QTc-prolonging drugs in drug regimen before and after lung transplantation
  • influence of long-term neo-macrolide (e.g. azithromycin) on QTc interval after lung transplantation
  • intra-individual difference of QTc interval before and after lung transplantation
  • incidence of any QTc-interval prolongation(>440 msec ) after lung transplantation
  • incidence of any QTc-interval prolongation (>440 msec or increase by 50msec or above) after initiation of new QTc prolonging drugs (especially neo-macrolides)
  • reversal of QTc-interval prolongation (440 msec or lower or decrease by 50msec or above) after stopping any QTc prolonging drug
  • Assessment of safety:
  • Incidence of new onset heart rhythm disorder during 6 months of follow-up

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

  • outpatients after lung transplantation (single, double or combined)
  • outpatients on the wait list for lung transplantation

排除标准

  • no informed consent

结局指标

主要结局

prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation

时间窗: 6 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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