Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- measure of reactive hyperemia-peripheral artery tone index
研究概览
简要总结
The aim of the study is to assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial function and the severity of the IPF.
详细描述
The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the forced expiratory volume at one second (FEV1), the forced vital capacity (FVC) and the total lung capacity (TLC) and the diffusing capacity of the lung for carbon monoxide (DLCO). The dyspnea will be assessed with the New York Heart Association (NYHA) score. The exercise capacity will be assessed by the 6-min walk test. Pulmonary arterial pressure will be recorded through cardiac echography or catheterization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPF according to ATS/ERS 2011's criteria
- •Stable IPF (no reduction of FVC or DLCO of more than 10% and 15% respectively)
排除标准
- •Patients with a significant disease other than IPF. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
- •Pregnant or nursing women.
- •Non-pulmonary fibrosis
- •treatment by pulmonary vasodilators that cannot be stopped for 24 hours for the assessment of endothelial function
结局指标
主要结局
measure of reactive hyperemia-peripheral artery tone index
时间窗: day 1
次要结局
- measure of reactive hyperemia-peripheral artery tone index(3 years)
- endothelial function(1, 2 and 3 years)