NCT02380365Unknown不适用
QT-Prolongation in Lung Transplantation
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
- 否
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
研究点 (1)
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