Evaluating the long-term effects of endobronchial valve implantation on heart and muscle function in COPD patients
Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function in Patients With Lung Volume Reduction Surgery
This study is testing whether putting special valves in the lungs can improve heart and muscle function in people with COPD over the long term.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (BeiJing, Beijing) |
| Trial ID | NCT05775588 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the long-term effects of endobronchial valve implantation on cardiac and skeletal muscle function in patients with Chronic Obstructive Pulmonary Disease (COPD). Participants will undergo lung volume reduction surgery that includes the implantation of bronchial valves. The study will evaluate various health metrics to determine the impact of this intervention on heart and muscle performance over time. The goal is to provide insights into how this surgical approach can improve overall health in COPD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with COPD who meet specific lung function criteria and have significant emphysema damage.
Not a fit: Patients with severe respiratory failure or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance cardiac and muscle function in patients suffering from COPD.
How similar studies have performed: While there is ongoing research in this area, the specific approach of evaluating cardiac and muscle function post-endobronchial valve implantation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
BeiJing, Beijing
- China-Japan Friendship Hospital — BeiJing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Mingming Deng, MD
- Email: isdeng1017@163.com
- Phone: 86 18801336854
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.