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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775588
• Other study ID #: 2022-NHLHCRF-LX-01-0202-1
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: China-Japan Friendship Hospital
• Contact: Mingming Deng, MD
• Phone: 86 18801336854
• Email: isdeng1017[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Lung volume reduction surgery with endobronchial valve implantation
the patient would undergo Lung volume reduction surgery with endobronchial valve implantation

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

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