Clinical trial NCT05775588: 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
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Baseline ventricular volume
timeFrame: Baseline
measure: Ventricular volume （6 months after surgery）
timeFrame: 6 months after surgery
measure: Ventricular volume（12 months after surgery）
timeFrame: 12 months after surgery
measure: Baseline FEV1
timeFrame: Baseline
measure: FEV1 （6 months after surgery）
timeFrame: 6 months after surgery
measure: FEV1（12 months after surgery）
timeFrame: 12 months after surgery
measure: Baseline left Ventricular Ejection Fractions
timeFrame: Baseline
measure: Left Ventricular Ejection Fractions （6 months after surgery）
timeFrame: 6 months after surgery
measure: Left Ventricular Ejection Fractions （12 months after surgery）
timeFrame: 12 months after surgery
measure: Baseline exercise tolerance
timeFrame: Baseline
measure: Exercise tolerance （6 months after surgery）
timeFrame: 6 months after surgery
measure: Exercise tolerance （12 months after surgery）
timeFrame: 12 months after surgery
measure: Baseline health impairment and quality of life of patients Baseline health impairment and quality of life of patients
timeFrame: Baseline
measure: Health impairment and quality of life of patients （6 months after surgery）
timeFrame: 6 months after surgery
measure: Health impairment and quality of life of patients （12 months after surgery）
timeFrame: 12 months after surgery
measure: Baseline cross sectional area of rectus femoris
timeFrame: Baseline
measure: Cross sectional area of rectus femoris （6 months after surgery）
timeFrame: 6 months after surgery
measure: Cross sectional area of rectus femoris （12 months after surgery）
timeFrame: 12 months after surgery
measure: Baseline mmuscle strength of lower limb
timeFrame: Baseline
measure: Mmuscle strength of lower limb （6 months after surgery）
timeFrame: 6 months after surgery
measure: Mmuscle strength of lower limb （12 months after surgery）
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: BeiJing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: