Back to resultsLong-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lung volume reduction surgery with endobronchial valve implantation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lung volume reduction surgery group
Arm Description
Outcomes
Primary Outcome Measures
Baseline ventricular volume
cardiac magnetic resonance imaging
Ventricular volume （6 months after surgery）
cardiac magnetic resonance imaging
Ventricular volume（12 months after surgery）
cardiac magnetic resonance imaging
Baseline FEV1
Pulmonary function tests
FEV1 （6 months after surgery）
Pulmonary function tests
FEV1（12 months after surgery）
Pulmonary function tests
Baseline left Ventricular Ejection Fractions
Echocardiography
Left Ventricular Ejection Fractions （6 months after surgery）
Echocardiography
Left Ventricular Ejection Fractions （12 months after surgery）
Echocardiography
Baseline exercise tolerance
6-minute walk test
Exercise tolerance （6 months after surgery）
6-minute walk test
Exercise tolerance （12 months after surgery）
6-minute walk test
Baseline health impairment and quality of life of patients Baseline health impairment and quality of life of patients
St. George's Respiratory Questionnaire
Health impairment and quality of life of patients （6 months after surgery）
St. George's Respiratory Questionnaire
Health impairment and quality of life of patients （12 months after surgery）
St. George's Respiratory Questionnaire
Baseline cross sectional area of rectus femoris
Rectus femoris ultrasound
Cross sectional area of rectus femoris （6 months after surgery）
Rectus femoris ultrasound
Cross sectional area of rectus femoris （12 months after surgery）
Rectus femoris ultrasound
Baseline mmuscle strength of lower limb
Myometer
Mmuscle strength of lower limb （6 months after surgery）
Myometer
Mmuscle strength of lower limb （12 months after surgery）
Myometer
Secondary Outcome Measures
Full Information
NCT ID
NCT05775588
First Posted
February 23, 2023
Last Updated
March 16, 2023
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05775588
Brief Title
Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function
Official Title
Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function in Patients With Lung Volume Reduction Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 27, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lung volume reduction surgery group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Lung volume reduction surgery with endobronchial valve implantation
Intervention Description
the patient would undergo Lung volume reduction surgery with endobronchial valve implantation
Primary Outcome Measure Information:
Title
Baseline ventricular volume
Description
cardiac magnetic resonance imaging
Time Frame
Baseline
Title
Ventricular volume （6 months after surgery）
Description
cardiac magnetic resonance imaging
Time Frame
6 months after surgery
Title
Ventricular volume（12 months after surgery）
Description
cardiac magnetic resonance imaging
Time Frame
12 months after surgery
Title
Baseline FEV1
Description
Pulmonary function tests
Time Frame
Baseline
Title
FEV1 （6 months after surgery）
Description
Pulmonary function tests
Time Frame
6 months after surgery
Title
FEV1（12 months after surgery）
Description
Pulmonary function tests
Time Frame
12 months after surgery
Title
Baseline left Ventricular Ejection Fractions
Description
Echocardiography
Time Frame
Baseline
Title
Left Ventricular Ejection Fractions （6 months after surgery）
Description
Echocardiography
Time Frame
6 months after surgery
Title
Left Ventricular Ejection Fractions （12 months after surgery）
Description
Echocardiography
Time Frame
12 months after surgery
Title
Baseline exercise tolerance
Description
6-minute walk test
Time Frame
Baseline
Title
Exercise tolerance （6 months after surgery）
Description
6-minute walk test
Time Frame
6 months after surgery
Title
Exercise tolerance （12 months after surgery）
Description
6-minute walk test
Time Frame
12 months after surgery
Title
Baseline health impairment and quality of life of patients Baseline health impairment and quality of life of patients
Description
St. George's Respiratory Questionnaire
Time Frame
Baseline
Title
Health impairment and quality of life of patients （6 months after surgery）
Description
St. George's Respiratory Questionnaire
Time Frame
6 months after surgery
Title
Health impairment and quality of life of patients （12 months after surgery）
Description
St. George's Respiratory Questionnaire
Time Frame
12 months after surgery
Title
Baseline cross sectional area of rectus femoris
Description
Rectus femoris ultrasound
Time Frame
Baseline
Title
Cross sectional area of rectus femoris （6 months after surgery）
Description
Rectus femoris ultrasound
Time Frame
6 months after surgery
Title
Cross sectional area of rectus femoris （12 months after surgery）
Description
Rectus femoris ultrasound
Time Frame
12 months after surgery
Title
Baseline mmuscle strength of lower limb
Description
Myometer
Time Frame
Baseline
Title
Mmuscle strength of lower limb （6 months after surgery）
Description
Myometer
Time Frame
6 months after surgery
Title
Mmuscle strength of lower limb （12 months after surgery）
Description
Myometer
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingming Deng, MD
Phone
86 18801336854
Email
isdeng1017@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qin Zhang, MD
Phone
86 18990236167
Email
zhangqincmu@163.com
12. IPD Sharing Statement
Learn more about this trial
Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function
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