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

NCT05775588 | Recruiting

• 1 other identifier: 2022-NHLHCRF-LX-01-0202-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (21)

• 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

Study Arms (1)

Lung volume reduction surgery group

EXPERIMENTAL

Procedure: Lung volume reduction surgery with endobronchial valve implantation

Interventions

Lung volume reduction surgery with endobronchial valve implantation PROCEDURE

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

Lung volume reduction surgery group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• PaCO2\>8.0 kPa, or PaO2\<6.0 kPa
• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

Mingming Deng, MD

CONTACT

86 18801336854; isdeng1017@163.com

Qin Zhang, MD

CONTACT

86 18990236167; zhangqincmu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 20, 2023
• Study Start: March 27, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CN (1)