NCT06935825 Respiratory Muscles in End-stage Lung Disease: Pathophysiological Processes & Clinical Consequences
| NCT ID | NCT06935825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | COPD |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-09-01 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: In patients with chronic lung diseases, the role of respiratory muscle dysfunction has been underestimated. Also, current treatment options, like chronic NIV and lung transplantation (LTx), might also have deleterious effects on the respiratory muscles, and the mechanisms are poorly understood. Therefore in this exploratory study the objectives are to: 1. Determine in vivo respiratory muscle function and progression of respiratory muscle dys-function in end-stage COPD patients 2. Establish the correlation between changes in the structure and contractility of respiratory myofibers and in vivo respiratory muscle function. 3. Establish the effect of chronic NIV on structure and contractility of respiratory muscle fi-bers 4. Determine whether the structure and contractility of respiratory muscles cells at the time of LTx predicts clinical recovery post-LTx. Study design: The study will be an exploratory observational cohort study following patients on the LTx waiting list during the waiting period and afterwards until they showed functional recovery of respiratory muscle function. Study population: Adult COPD patients on the LTx waiting list will be included. Intervention (if applicable): None Main study parameters/endpoints: To assess clinical functioning of the respiratory muscles we will assess respiratory electrical activity as a measure of respiratory effort by surface EMG, and thickening fraction of the diaphragm and intercostal muscles and diaphragm excursions by ultrasound and maximal in- and expiratory pressure to assess muscle output; all before and after LTx. We will relate and correct these data for hyperinflation and degree of lung damage by using data from standard care lung function tests and CT scans, and will relate these measurements to prior treatment (NIV settings) and outcome after LTx, by retrieving these data from the EPD. To assess contractility of respiratory myofibers and in vivo respiratory muscle function, biopsies will be taken during LTx surgery and the biopsies will be analyzed in the lab of Prof. Ottenheijm (AmsterdamUMC) for individual myofiber functioning (strength, calcium sensitivity, myofiber characteristics) and in the lab of Dr. Pouwels for extracellular matrix characteristics. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Overall, risks are believed to be minimal. The clinical measurements are non-invasive and/or regular performed in clinical practice. Also, we decided to do those measurements during regular control visits, limiting the burden for the patients. Taking biopsies from the respiratory muscles during surgery has been extensively performed without any risk; the biobank of the Ottenheijm group contains \> 500 samples and never any complication has been observed. Also, in preparation of the present study we performed a pilot study in 12 COPD patients of whom.. biopsies were taken at the UMCG without side effects or complications. The biopsies will be done with the patients being under full anesthesia, so participants will feel no discomfort.
Eligibility Criteria
In order to be eligible to participate in this study, a participant must meet all of the following criteria: * Age \> 18 years old * Severe COPD defined as COPD GOLD stage III or IV (FEV1 \< 50% of predicted; FEV1/FVC ratio \< 70%, no significant reversibility, smoking history of at least 10 pack-years). * Being on the lung transplant waiting list * Being able to understand the patient information and provide written informed consent for participation in the study A potential participant who meets any of the following criteria will be excluded from participation in this study: * Patients suffering from acute conditions at the time of inclusion or LTx * Patients using more than 20 mg of morphine, or an equivalent, or more than 20 mg oxazepam, or an equivalent, at the time of inclusion or LTx
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06935825 clinical trial?
This trial is open to participants of all sexes, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06935825 currently recruiting?
Yes, NCT06935825 is actively recruiting participants. Contact the research team at m.l.duiverman@umcg.nl for enrollment information.
Where is the NCT06935825 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Groningen, Netherlands, Nijmegen, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT06935825 clinical trial?
NCT06935825 is sponsored by University Medical Center Groningen. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.