Status:
COMPLETED
Unraveling Mechanism of Action of Extracorporeal Photopheresis in Heart and Lung Transplant Patients
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Heart Transplanted Patients
Lung Transplanted Patients
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective observational single center national study. Lung and heart transplant patients with a definite diagnosis of chronic lung allograft dysfunction (CLAD) or cardiac allograft vasculo...
Detailed Description
The primary objective of the present study is to identify the biomarkers associated to response to ECP after 6 months of treatment.
Eligibility Criteria
Inclusion
- Lung transplanted patients will be enrolled according to current per center protocol at diagnosis of established CLAD grade 1-2 (diagnosis will be made according to published guidelines) . Rate of graft function decline will be classified as rapid (\>/= 100 ml/month) or slow (\< 100ml/month) during the 6 months preceding ECP treatment. All patients will be diagnosed as CLAD after a failure of a 3-month trial with azithromycin. They will be enrolled in ECP treatment at CLAD grade 1-2. ECP response will be assessed after 6 months of treatment and patients experiencing \> 10% decline with respect to baseline value at ECP initiation in graft function will be classified as non-responders.Heart transplanted patients with demonstrated CAV in a recent angiography (\<6 months) in absence of acute cellular or antibodies mediated rejection at myocardial biopsy, will be enrolled The diagnosis of CAV will require the presence of thickening of the arterial intima in any epicardial artery.
Exclusion
Key Trial Info
Start Date :
April 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06899828
Start Date
April 17 2023
End Date
July 31 2024
Last Update
March 28 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy, 27100