Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: Lung volume reduction surgery with endobronchial valve implantation

• Registration Number: NCT05775588
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-20
• Study Start: 2023-03-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung volume reduction surgery group	Lung volume reduction surgery with endobronchial valve implantation	-

Primary Outcome Measures

Name	Time	Method
Baseline ventricular volume	Baseline	cardiac magnetic resonance imaging
FEV1 （6 months after surgery）	6 months after surgery	Pulmonary function tests
Left Ventricular Ejection Fractions （6 months after surgery）	6 months after surgery	Echocardiography
Baseline exercise tolerance	Baseline	6-minute walk test
Baseline health impairment and quality of life of patients Baseline health impairment and quality of life of patients	Baseline	St. George's Respiratory Questionnaire
Health impairment and quality of life of patients （6 months after surgery）	6 months after surgery	St. George's Respiratory Questionnaire
Baseline mmuscle strength of lower limb	Baseline	Myometer
Ventricular volume（12 months after surgery）	12 months after surgery	cardiac magnetic resonance imaging
Left Ventricular Ejection Fractions （12 months after surgery）	12 months after surgery	Echocardiography
Exercise tolerance （12 months after surgery）	12 months after surgery	6-minute walk test
Baseline FEV1	Baseline	Pulmonary function tests
Health impairment and quality of life of patients （12 months after surgery）	12 months after surgery	St. George's Respiratory Questionnaire
Cross sectional area of rectus femoris （6 months after surgery）	6 months after surgery	Rectus femoris ultrasound
Mmuscle strength of lower limb （12 months after surgery）	12 months after surgery	Myometer
Ventricular volume （6 months after surgery）	6 months after surgery	cardiac magnetic resonance imaging
FEV1（12 months after surgery）	12 months after surgery	Pulmonary function tests
Baseline left Ventricular Ejection Fractions	Baseline	Echocardiography
Exercise tolerance （6 months after surgery）	6 months after surgery	6-minute walk test
Baseline cross sectional area of rectus femoris	Baseline	Rectus femoris ultrasound
Cross sectional area of rectus femoris （12 months after surgery）	12 months after surgery	Rectus femoris ultrasound
Mmuscle strength of lower limb （6 months after surgery）	6 months after surgery	Myometer

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 BeiJing, Beijing, China