Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes

Recruiting

• Conditions: Solid Organ Transplantation

• Registration Number: NCT06774339
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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):

* Heart Failure and Transplants (heart-lung)

* Internal Medicine for the Treatment of Severe Organ Failures (liver)

* Nephrology, Dialysis, and Transplantation (kidney).

Detailed Description

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.

Study Timeline

• Study Start: 2024-10-10
• Status Verified: 2024-12
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2031-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Adult patients (≥ 18 years old at the time of enrollment) who have undergone at least one of the following: Liver transplant, Kidney transplant, Heart transplant, Lung transplant during the study period.
• Informed consent acquisition.

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events in Heart Transplantation	7 years	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.
Adverse Events in Liver Transplantation	7 years	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)
Adverse Events in Lung Transplantation	7 years	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.
Adverse Events in Kidney Transplantation	7 years	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).

Trial Locations

Locations (1)

IRCCS - Azienda ospedaliero-universitaria di Bologna; 🇮🇹 Bologna, Italy