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

Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function in Patients With Lung Volume Reduction Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Procedure: Lung volume reduction surgery with endobronchial valve implantation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingming Deng, MD; Phone Number: 86 18801336854; Email: isdeng1017@163.com
• Study Contact Backup: Name: Qin Zhang, MD; Phone Number: 86 18990236167; Email: zhangqincmu@163.com

Study Locations

• China
  • Beijing
    • BeiJing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Gang Hou, Professor; Phone Number: 13840065481; Email: hougangcmu@163.com
      • Contact: Mingming Deng, Doctor; Phone Number: 18801336854; Email: isdeng1017@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung volume reduction surgery group	Procedure: Lung volume reduction surgery with endobronchial valve implantation; the patient would undergo Lung volume reduction surgery with endobronchial valve implantation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2022-NHLHCRF-LX-01-0202-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No