Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients

Not yet recruiting

• Conditions: Artificial Intelligence (AI); Hepatocellular Carcinoma (HCC); Liver Transplantation; Machine Learning; Heart Transplantation; Major Cardiovascular Event

• Registration Number: NCT06774768
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

This is an observational, low risk tissue based, non-pharmacological, retrospective-prospective study for adults heart and liver transplant patients, related to IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO).

This clinical study is part of the national multicentric project DARE. The project has the wide overarching aim to develop digital solutions for personalized healthcare.

Detailed Description

This study is structured in two phases: 1) a retrospective phase that aims to develop ML-based scores that can allow to predict at patient level the risk of infections, cardiovascular diseases, new onset malignancies and chronic graft dysfunction, and describing the trajectory of this risk over time; 2) a prospective phase in which we test the association of biomarkers, QoL and frailty assessments with the ML-scores applied prospectively in heart and liver transplant recipients.

Study Timeline

• 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
• Study Start: 2025-01-30
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Cardiovascular Event (MACE)	4 years	Major Cardiovascular Event (MACE) defined as, fatal or non-fatal myocardial infarction, ischemic or hemorrhagic stroke, admission for heart failure, new onset arrhythmia, new onset symptoms for peripheral artery diseases
Chronic graft dysfunction	4 years	Chronic graft dysfunction; in HTX recipients defined as onset of one or more of the following: CAV grade 2 or greater as diagnosed by standard of care coronary angiography; diffuse fibrosis with signs of diastolic or systolic left ventricle dysfunction. In LTX we define chronic graft dysfunction as progressive fibrosis, cholestasis and reduced protein synthesis, portal hypertension.
Infection	4 years	Infection, defined as systemic or organ-specific syndrome characterized by evidence of inflammatory response, abnormal organ function, and need for intravenous antimicrobial treatment, with or without microbiological isolate.
New onset malignancy	4 years	New onset malignancy, defined as hematopoietic or solid malignant neoplasm, developing after transplantation

Secondary Outcome Measures

Name	Time	Method
ML-Scores as Surrogate Endpoints	4 years	The ML-scores developed to predict the primary outcomes will be used as secondary study outcomes for the prospective phase of the study, and will be tested as surrogate endpoints for clinical outcomes. In this approach, we will analyze the association between such defined surrogate endpoints and biomarkers, QoL and cognitive scores, and frailty measurements.

Trial Locations

Locations (1)

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