Status:
NOT_YET_RECRUITING
Respiratory Muscles in End-stage Lung Disease: Pathophysiological Processes & Clinical Consequences
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Erasmus Medical Center
Amsterdam UMC, location VUmc
Conditions:
COPD
Eligibility:
All Genders
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),...
Detailed Description
Considering that a) there is a substantial proportion of patients with severe COPD that develop respiratory muscle dysfunction-induced CHRF; b) respiratory pump failure results in significant morbidit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06935825
Start Date
September 1 2025
End Date
September 1 2029
Last Update
April 20 2025
Active Locations (4)
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1
Amsterdam University Medical Center
Amsterdam, Netherlands
2
University Medical Center Groningen
Groningen, Netherlands
3
Radboud University Medical Center
Nijmegen, Netherlands
4
Erasmus Medical Center
Rotterdam, Netherlands