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临床试验/NCT00949195
NCT00949195Unknown不适用

Pulmonary Arterial Pressure Response During Exercise in COPD and Healthy Subjects

Szeged University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
The degree of pulmonary artery pressure change during exercise?

研究概览

简要总结

Background:

The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.

Methods:

Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.

Primary endpoint:

The degree of pulmonary artery systolic pressure change during exercise?

Secondary endpoint:

  1. The degree of right ventricular function change during exercise?
  2. Is endothel dysfunction manifested with pulmonary artery pressure rise?
  3. What is the correlation between the systemic inflammatory marker hsCRP and the degree of pulmonary artery pressure rise?

详细描述

Background: The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise by semi-supine echocardiography and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.

Methods: Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. All of the subjects perform complete lung function with body pletysmography and diffusion capacity measurement. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD patients (age between 45 and 70)
  • with moderate to severe obstruction (FEV1<60%pred) and
  • healthy subjects (age between 45 and 70, (FEV1>80%pred, FEV1/FVC>70%

排除标准

  • Not in the age range
  • Different FEV1 value
  • Severe comorbidities

结局指标

主要结局

The degree of pulmonary artery pressure change during exercise?

时间窗: 2 months

次要结局

  • Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction?(2 months)

研究者

发起方
Szeged University
申办方类型
Other

研究点 (1)

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