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

China-Japan Friendship Hospital40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Lung volume reduction surgery with endobronchial valve implantationPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Baseline ventricular volume

cardiac magnetic resonance imaging

Time frame: Baseline

Ventricular volume （6 months after surgery）

cardiac magnetic resonance imaging

Time frame: 6 months after surgery

Ventricular volume（12 months after surgery）

cardiac magnetic resonance imaging

Time frame: 12 months after surgery

Baseline FEV1

Pulmonary function tests

Time frame: Baseline

FEV1 （6 months after surgery）

Pulmonary function tests

Time frame: 6 months after surgery

FEV1（12 months after surgery）

Pulmonary function tests

Time frame: 12 months after surgery

Baseline left Ventricular Ejection Fractions

Echocardiography

Time frame: Baseline

Left Ventricular Ejection Fractions （6 months after surgery）

Echocardiography

Time frame: 6 months after surgery

Left Ventricular Ejection Fractions （12 months after surgery）

Echocardiography

Time frame: 12 months after surgery

Baseline exercise tolerance

Central Contacts

Mingming Deng, MD

CONTACT

86 18801336854 isdeng1017@163.com

Qin Zhang, MD

CONTACT

86 18990236167 zhangqincmu@163.com

Data from ClinicalTrials.gov

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