Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function in Patients With Lung Volume Reduction Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Ventricular volume（12 months after surgery）
研究概览
简要总结
The goal of this type of study: clinical trial is to evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function.
Participants will undergo Lung volume reduction surgery with endobronchial valve implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Chronic Obstructive Pulmonary Disease
- •FEV1 ≤ 45% pred and FEV1/FVC<70%
- •TLC>100% pred and RV>175% pred
- •CAT score≥18
- •Emphysema damage>50%
- •Complete interlobar fissure >95% based on quantitative analysis of CT measurement
- •No smoking>6 months
- •Sign the informed consent form
排除标准
- •PaCO2>8.0 kPa, or PaO2<6.0 kPa
- •6-minute walk test<160m
- •Obvious chronic bronchitis, bronchiectasis or other infectious pulmonary diseases
- •More than 3 hospitalizations for pulmonary infection in the past 12 months before baseline assessment
- •Previous lobectomy, LVRS or lung transplantation
- •LVEF<45% and or RVSP>50mmHg
- •Anticoagulant therapy that cannot be stopped before surgery
- •Patients with obvious immune deficiency
- •Participated in other lung drug studies within the first 30 days of this study
- •Pulmonary nodules requiring intervention
- •Any disease or condition that interferes with the completion of the initial or subsequent assessment
研究组 & 干预措施
Lung volume reduction surgery group
干预措施: Lung volume reduction surgery with endobronchial valve implantation (Procedure)
结局指标
主要结局
Ventricular volume（12 months after surgery）
时间窗: 12 months after surgery
cardiac magnetic resonance imaging
Left Ventricular Ejection Fractions （12 months after surgery）
时间窗: 12 months after surgery
Echocardiography
Exercise tolerance （12 months after surgery）
时间窗: 12 months after surgery
6-minute walk test
Baseline FEV1
时间窗: Baseline
Pulmonary function tests
Health impairment and quality of life of patients （12 months after surgery）
时间窗: 12 months after surgery
St. George's Respiratory Questionnaire
Cross sectional area of rectus femoris （6 months after surgery）
时间窗: 6 months after surgery
Rectus femoris ultrasound
Mmuscle strength of lower limb （12 months after surgery）
时间窗: 12 months after surgery
Myometer
Ventricular volume （6 months after surgery）
时间窗: 6 months after surgery
cardiac magnetic resonance imaging
FEV1（12 months after surgery）
时间窗: 12 months after surgery
Pulmonary function tests
Baseline left Ventricular Ejection Fractions
时间窗: Baseline
Echocardiography
Exercise tolerance （6 months after surgery）
时间窗: 6 months after surgery
6-minute walk test
Baseline ventricular volume
时间窗: Baseline
cardiac magnetic resonance imaging
FEV1 （6 months after surgery）
时间窗: 6 months after surgery
Pulmonary function tests
Left Ventricular Ejection Fractions （6 months after surgery）
时间窗: 6 months after surgery
Echocardiography
Baseline exercise tolerance
时间窗: Baseline
6-minute walk test
Baseline health impairment and quality of life of patients Baseline health impairment and quality of life of patients
时间窗: Baseline
St. George's Respiratory Questionnaire
Health impairment and quality of life of patients （6 months after surgery）
时间窗: 6 months after surgery
St. George's Respiratory Questionnaire
Baseline mmuscle strength of lower limb
时间窗: Baseline
Myometer
Baseline cross sectional area of rectus femoris
时间窗: Baseline
Rectus femoris ultrasound
Cross sectional area of rectus femoris （12 months after surgery）
时间窗: 12 months after surgery
Rectus femoris ultrasound
Mmuscle strength of lower limb （6 months after surgery）
时间窗: 6 months after surgery
Myometer
次要结局
未报告次要终点
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital