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临床试验/NCT04035148
NCT04035148Unknown不适用

Cardiopulmonary Exercise Test in Evaluation of Pulmonary Hypertension in COPD Patients

Assiut University0 个研究点目标入组 50 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)

研究概览

简要总结

  • To evaluate the entire course of exercise during CPET in COPD patients.
  • To study whether CPET, PFTs and arterial blood gases could discriminate between COPD patients with and without PH.
  • To study whether the existence of pulmonary hypertension in COPD is related to characteristic findings in gas exchange and circulatory parameters during cardiopulmonary exercise testing (CPET).

详细描述

(COPD) is a common cause of pre-capillary pulmonary hypertension (PH). Pulmonary hypertension (PHT) is a common complication of COPD and is determinant for the prognosis of COPD.

PHT is defined as A mean PAP of ≥ 25 mmHg measured by right heart catheterization at rest.

Exercise tolerance in patients with COPD is reduced due to ventilatory limitation, gas exchange abnormalities, and deconditioning as the disease progresses, and this may impair functional capacity and the quality of life.

COPD patients usually terminate physical activity when the ventilatory requirement exceeds their maximal ventilatory capacity.

If they have PH, the altered hemodynamic response may reduce their exercise capacity further.

研究设计

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

入排标准

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

入选标准

  • Stable COPD patients
  • with age ≥ 40 years.
  • Prior to inclusion, the COPD diagnosis was verified by spirometry before and after bronchodilation.
  • treatment was optimized and Patients on regular medication.

排除标准

  • Patients who refuse to participate in the study.
  • Patients underwent thorough pulmonary and cardiologic preinclusion screening, and those with pulmonary disease other than COPD and emphysema.
  • arrhythmia
  • valvular or coronary heart disease
  • left ventricle dysfunction
  • obstructive sleep apnea syndrome
  • pulmonary embolism
  • systemic hypertension ≥160/90 mmHg
  • inflammatory disease
  • hyperthyroidism
  • renal failure
  • inability to exercise (due to orthopedic, neurologic or musculoskeletal problem).

结局指标

主要结局

Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)

时间窗: Baseline

For the assessment whether the existence of pulmonary hypertension in COPD is related to characteristic findings during cardiopulmonary exercise testing (CPET).

Measurement the arterial pO2 in mmHg and arterial pCO2 at baseline

时间窗: Baseline

The blood gases pO2 and pCO2 are taken to characterize the gas exchange during cardiopulmonary exercise which is a routine procedure

次要结局

  • measurement of symptoms quantified by COPD Assessment Test (CAT Assessment)- total score 40.(Baseline)
  • measurement of dyspnoea quantified by the modified Medical Research Council (mMRC) Dyspnea Scale (grades from 0 to 4 )(Baseline)
  • Measurement of FEV1(Baseline)
  • Measurement of Breathing reserve during cardiopulmonary exercise testing(Baseline)
  • Measurement of Oxygen pulse during cardiopulmonary exercise testing(Baseline)
  • Presence of cardiovascular comorbidities(Baseline)

研究者

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

Amira Emad El-din Abdalah

Principal investigator

Assiut University

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CPET in Evaluation of PH in COPD Patients | 临床试验