An observational study in Solid Organ Transplantation, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
This is a prospective, tissue-based, low-risk, non-pharmacological study that will include adult patients undergoing solid organ transplantation (heart, liver, lung, kidney) followed at the following Units of the IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO):
The aim of this study is to perform objective biological measurements of inflammation and cellular senescence (i.e., plasma profiles of cytokines, inflammatory miRNAs, circulating free DNA, extracellular vesicles), immunosenescence (i.e., circulating and tissue-based leukocyte profiles of aging), and systemic and tissue aging (i.e., epigenetic clocks) in the collected cohort. These measures may help to stratify patients at higher risk of transplant failure (graft damage) or those at higher risk of cardiovascular, renal, metabolic, neoplastic complications, or increased mortality. Additionally, the study aims to implement therapeutic or prophylactic measures based on biological stratification to prevent the progression of biological damage.
It is also important to highlight that the identification of markers of cellular senescence, immunosenescence, and epigenetic aging in the recipient could define patterns that guide more appropriate and personalized immunosuppressive treatments.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 250 is above the median of 95 across 895 observational studies indexed under Inflammation.
Browse Inflammation studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adult patients listed for solid organ transplantation (liver, kidney, heart, lung) at the IRCCS Azienda Ospedaliero-Universitaria di Bologna will be enrolled during the study period.
Exclusion Criteria:
Adverse Events in Heart Transplantation
We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Primary Graft Dysfunction (PGD), Acute Rejection, Death from any cause, Chronic Rejection, and Major Infectious Complications.
Time frame: 7 years
Adverse Events in Liver Transplantation
We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Primary Graft Dysfunction (PGD), Acute Rejection, Death from any cause, Chronic Rejection, Major Infectious Complications and Major Cardiovascular Complications (MACE)
Time frame: 7 years
Adverse Events in Lung Transplantation
We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Acute Rejection, Death from any cause, Chronic Rejection, Major Infectious Complications and Endoscopic Complications.
Time frame: 7 years
Adverse Events in Kidney Transplantation
We will assess post-heart transplant adverse events based on Primary Non-Function (PNF), Delayed Graft Function (DGF), Acute Rejection, Graft Loss, Death from any cause, Chronic Rejection, and Major Cardiovascular Complications (MACE).
Time frame: 7 years
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IRCCS Azienda Ospedaliero-Universitaria di Bologna