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OpenTrials
Completed

NCT Number: NCT06899828

Unraveling Mechanism of Action of Extracorporeal Photopheresis in Heart and Lung Transplant Patients

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 vasculopathy (CAV) will be assigned for extracorporeal photopheresis (ECP) as per common clinical practice to a 6-month ECP cycle with the aim of limiting progression of organ dysfunction. The exact mechanisms of ECP in chronic rejection after lung and heart transplantation (CLAD and CAV) are elusive but it is thought to induce apoptosis of lymphocytes and to generate regulatory T cells, which modulate transplant immune rejection by a complex effect.

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Key information

Conditions

Heart Transplanted Patients Cardiac Allograft Vasculopathy Chronic Lung Allograft Dysfunction (CLAD) Lung Transplanted Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

About this study

The primary objective of the present study is to identify the biomarkers associated to response to ECP after 6 months of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. identification the primary mechanism of action of ECP in CLAD and CAV by analyzing biological markers (such as relative expression levels of microRNAs, potentially involved in immune regulation), associated to response to a 6 month-ECP treatment course

    Time frame: After 6 months from ECP treatment

Secondary outcomes

  1. Correlation between up-regulation or down-regulation of miRNAs at 6 months of therapy respect to baseline and other immune variables (regulatory T cells activation and differentiation, inflammatory cytokines levels and presence of anti-HLA antibodies)

    Time frame: After 6 months of therapy

  2. Evaluation the effectiveness of ECP

    Time frame: After 2 years of follow-up from ECP

    Evaluation the effectiveness of ECP in reducing cardiovascular mortality and preventing percutaneous myocardial revascularization and hospitalization by cardiovascular causes at 2 years of follow-up in comparison to a control population of heart transplant recipients with CAV included in our historical archive

  3. Effect of ECP on progression of myocardial fibrosis evaluated at CMR

    Time frame: After 6 months of treatment

  4. Effect of ECP on ventricular function evaluated at echocardiography

    Time frame: After 6 months of treatment

  5. Trend of heart failure biomarkers (NT proBNP or BNP) after 6 months of treatment

    Time frame: After 6 months of treatment

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: URRAH

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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