Heart Transplanted PatientsURRAHNCT06899828
Unraveling Mechanism of Action of Extracorporeal Photopheresis in Heart and Lung Transplant Patients
An observational study of Heart Transplanted Patients and Lung Transplanted Patients, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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 vasculopathy (CAV) will be assigned for extracorporeal photopheresis (ECP) as per common clinical practice to a 6-month ECP… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplanted Patients, Lung Transplanted Patients, Chronic Lung Allograft Dysfunction (CLAD)
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart and lung transplant patients who receive diagnosis of chronic lung allograft dysfunction (CLAD) or cardiac allograft vasculopathy (CAV)
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The primary objective of the present study is to identify the biomarkers associated to response to ECP after 6 months of treatment.
- Conditions
- Heart Transplanted Patients, Lung Transplanted Patients, Chronic Lung Allograft Dysfunction (CLAD), Cardiac Allograft Vasculopathy
- Keywords
- ECP, heart and lung rejection, miRNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung transplanted patients who receive diagnosis of chronic lung allograft dysfunction (CLAD) | Not described | |
| Heart transplanted patients who receive diagnosis of cardiac allograft vasculopathy (CAV) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 6 months from ECP treatment
Secondary outcomes (5)
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)
Measured: After 6 months of therapy
Evaluation the effectiveness of 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
Measured: After 2 years of follow-up from ECP
Effect of ECP on progression of myocardial fibrosis evaluated at CMR
Measured: After 6 months of treatment
Effect of ECP on ventricular function evaluated at echocardiography
Measured: After 6 months of treatment
Trend of heart failure biomarkers (NT proBNP or BNP) after 6 months of treatment
Measured: After 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start17 Apr 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplanted PatientsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Del Fante, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899828
- Sponsor's protocol ID
- URRAH
- Acronym
- URRAH
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling Mechanism of Action of Extracorporeal Photopheresis in Heart and Lung Transplant Patients
- ClinicalTrials.gov ID
- NCT06899828
- Acronym / sponsor ID
- URRAH / URRAH
- Conditions
- Heart Transplanted Patients, Lung Transplanted Patients, Chronic Lung Allograft Dysfunction (CLAD), Cardiac Allograft Vasculopathy
- Keywords
- ECP, heart and lung rejection, miRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of the present study is to identify the biomarkers associated to response to ECP after 6 months of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung transplanted patients who receive diagnosis of chronic lung allograft dysfunction (CLAD) | – | – |
| Heart transplanted patients who receive diagnosis of cardiac allograft vasculopathy (CAV) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart and lung transplant patients who receive diagnosis of chronic lung allograft dysfunction (CLAD) or cardiac allograft vasculopathy (CAV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Evaluation the effectiveness of ECP
Time frame: After 2 years of follow-up from ECP
Effect of ECP on progression of myocardial fibrosis evaluated at CMR
Time frame: After 6 months of treatment
Effect of ECP on ventricular function evaluated at echocardiography
Time frame: After 6 months of treatment
Trend of heart failure biomarkers (NT proBNP or BNP) after 6 months of treatment
Time frame: After 6 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplanted Patients and Lung Transplanted Patients, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.