Chronic Obstructive Pulmonary DiseaseNCT05775588
Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function
A study testing Lung volume reduction surgery with endobronchial valve implantation in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Lung volume reduction surgery with endobronchial valve implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Gang Hou, Professor, 13840065481, hougangcmu@163.com
Mingming Deng, Doctor, 18801336854, isdeng1017@163.com
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Lung volume reduction surgery with endobronchial valve implantation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung volume reduction surgery with endobronchial valve implantationProcedure or surgery
the patient would undergo Lung volume reduction surgery with endobronchial valve implantation
| Study group | Role | What they receive |
|---|---|---|
| Lung volume reduction surgery group | Experimental | Not described Receives: Procedure: Lung volume reduction surgery with endobronchial valve implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline ventricular volume
cardiac magnetic resonance imaging
Measured: Baseline
Ventricular volume （6 months after surgery）
cardiac magnetic resonance imaging
Measured: 6 months after surgery
Ventricular volume（12 months after surgery）
cardiac magnetic resonance imaging
Measured: 12 months after surgery
Baseline FEV1
Pulmonary function tests
Measured: Baseline
FEV1 （6 months after surgery）
Pulmonary function tests
Measured: 6 months after surgery
FEV1（12 months after surgery）
Pulmonary function tests
Measured: 12 months after surgery
Baseline left Ventricular Ejection Fractions
Echocardiography
Measured: Baseline
Left Ventricular Ejection Fractions （6 months after surgery）
Echocardiography
Measured: 6 months after surgery
Left Ventricular Ejection Fractions （12 months after surgery）
Echocardiography
Measured: 12 months after surgery
Baseline exercise tolerance
6-minute walk test
Measured: Baseline
Exercise tolerance （6 months after surgery）
6-minute walk test
Measured: 6 months after surgery
Exercise tolerance （12 months after surgery）
6-minute walk test
Measured: 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
Measured: Baseline
Health impairment and quality of life of patients （6 months after surgery）
St. George's Respiratory Questionnaire
Measured: 6 months after surgery
Health impairment and quality of life of patients （12 months after surgery）
St. George's Respiratory Questionnaire
Measured: 12 months after surgery
Baseline cross sectional area of rectus femoris
Rectus femoris ultrasound
Measured: Baseline
Cross sectional area of rectus femoris （6 months after surgery）
Rectus femoris ultrasound
Measured: 6 months after surgery
Cross sectional area of rectus femoris （12 months after surgery）
Rectus femoris ultrasound
Measured: 12 months after surgery
Baseline mmuscle strength of lower limb
Myometer
Measured: Baseline
Mmuscle strength of lower limb （6 months after surgery）
Myometer
Measured: 6 months after surgery
Mmuscle strength of lower limb （12 months after surgery）
Myometer
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start27 Mar 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775588
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0202-1
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function in Patients With Lung Volume Reduction Surgery
- ClinicalTrials.gov ID
- NCT05775588
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0202-1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung volume reduction surgery group | Experimental | Procedure: Lung volume reduction surgery with endobronchial valve implantation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung volume reduction surgery with endobronchial valve implantationthe patient would undergo Lung volume reduction surgery with endobronchial valve implantation | Procedure or surgery | Lung volume reduction surgery group |
Primary outcome
Baseline ventricular volume
Time frame: Baseline
cardiac magnetic resonance imaging
Ventricular volume （6 months after surgery）
Time frame: 6 months after surgery
cardiac magnetic resonance imaging
Ventricular volume（12 months after surgery）
Time frame: 12 months after surgery
cardiac magnetic resonance imaging
Baseline FEV1
Time frame: Baseline
Pulmonary function tests
FEV1 （6 months after surgery）
Time frame: 6 months after surgery
Pulmonary function tests
FEV1（12 months after surgery）
Time frame: 12 months after surgery
Pulmonary function tests
Baseline left Ventricular Ejection Fractions
Time frame: Baseline
Echocardiography
Left Ventricular Ejection Fractions （6 months after surgery）
Time frame: 6 months after surgery
Echocardiography
Left Ventricular Ejection Fractions （12 months after surgery）
Time frame: 12 months after surgery
Echocardiography
Baseline exercise tolerance
Time frame: Baseline
6-minute walk test
Exercise tolerance （6 months after surgery）
Time frame: 6 months after surgery
6-minute walk test
Exercise tolerance （12 months after surgery）
Time frame: 12 months after surgery
6-minute walk test
Baseline health impairment and quality of life of patients Baseline health impairment and quality of life of patients
Time frame: Baseline
St. George's Respiratory Questionnaire
Health impairment and quality of life of patients （6 months after surgery）
Time frame: 6 months after surgery
St. George's Respiratory Questionnaire
Health impairment and quality of life of patients （12 months after surgery）
Time frame: 12 months after surgery
St. George's Respiratory Questionnaire
Baseline cross sectional area of rectus femoris
Time frame: Baseline
Rectus femoris ultrasound
Cross sectional area of rectus femoris （6 months after surgery）
Time frame: 6 months after surgery
Rectus femoris ultrasound
Cross sectional area of rectus femoris （12 months after surgery）
Time frame: 12 months after surgery
Rectus femoris ultrasound
Baseline mmuscle strength of lower limb
Time frame: Baseline
Myometer
Mmuscle strength of lower limb （6 months after surgery）
Time frame: 6 months after surgery
Myometer
Mmuscle strength of lower limb （12 months after surgery）
Time frame: 12 months after surgery
Myometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung volume reduction surgery with endobronchial valve implantation in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingming Deng, MD (86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline ventricular volume (time frame: Baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.