Analysing cEllular bioenergetics aNd structural aDaptations in the qUadriceps muscle befoRe and After endobroNChial valve treatmEnt.
- Conditions
- COPDemphysema10038716
- Registration Number
- NL-OMON56839
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1. Patient is scheduled for a bronchoscopic lung volume treatment using Pulmonx
Zephyr one-way endobronchial valves;
2. Patient read, understood and signed the Informed Consent Form.
Exclusion Criteria
1. Inability to perform a cycle ergometry test;
2. Contraindications for undergoing a magnetic resonance imaging scan (e.g.
claustrophobia, implanted cardiac devices);
3. Body length >190cm;
4. Use of any anticoagulant therapy;
5. COPD exacerbation 4 weeks prior to testing.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is to assess the physiological adaptations,<br /><br>in terms of cellular bioenergetics, of the quadriceps muscle in patients with<br /><br>severe COPD in response to EBV treatment. This will be done by performing<br /><br>31P-MRS during exercise testing in a MR-compatible ergometer at baseline and at<br /><br>6 months follow-up, for which the following outcomes will be assessed:<br /><br>- Quadriceps phosphocreatine concentration (PCr) at rest and during progressive<br /><br>exercise;<br /><br>- Quadriceps inorganic phosphorus concentration (Pi) at rest and during<br /><br>progressive exercise;<br /><br>- Quadriceps pH at rest and during progressive exercise;<br /><br>- Post-exercise recovery rate of quadriceps PCr, Pi and pH.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint of this study is to investigate in muscle biopsies the<br /><br>following outcomes:<br /><br>- Change in muscle fiber type composition 6 months after EBV treatment.<br /><br>- Change in mitochondrial density 6 months after EBV treatment.<br /><br>- Change in master regulators of muscle oxidative programming 6 months after<br /><br>EBV treatment.<br /><br>- Change in mitochondrial respiration 6 months after EBV treatment.<br /><br>- Change in lipid droplets 6 months after EBV treatment.<br /><br>- Change in mRNA and protein expression of markers of inflammation and hypoxia<br /><br>induced signalling 6 months after EBV treatment.<br /><br>- Change in regulators of muscle protein turnover 6 months after EBV treatment. </p><br>