Clinical trial NCT06774768: Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients
Official title: Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Artificial Intelligence (AI)
Hepatocellular Carcinoma (HCC)
Heart Transplantation
Liver Transplantation
Machine Learning
Major Cardiovascular Event
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the retrospective phase we will include all patients receiving heart or liver transplantation between January 2008 and December 2020 and surviving at least 6 months after surgery.

In the prospective phase we will consider for enrolment all patients with heart or liver transplantation actively on follow-up at IRCCS AOUBO from January 2024 and January 2026.

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.

Eligibility criteria: Retrospective cohort Inclusion criteria Receiving a heart or liver transplantation at IRCCS AOUBO between January 2008 and December 2020.

Surviving at least 6 months after surgery Receiving at least one outpatient clinical assessment, comprising clinical evaluation, standard laboratory tests, and graft ultrasound Older than 18 years old

Exclusion criteria Unavailability of medical records in the standard data repositories of IRCCS AOUBO

Prospective cohort

Inclusion criteria Older thant 18 years old Receiving a heart or liver transplantation at least 6 months before study entry and being in active follow up at IRCCS AOUBO Obtaining informed consent

Exclusion criteria None

Primary outcomes:
measure: Infection
timeFrame: 4 years
measure: Major Cardiovascular Event (MACE)
timeFrame: 4 years
measure: New onset malignancy
timeFrame: 4 years
measure: Chronic graft dysfunction
timeFrame: 4 years
Secondary outcomes:
measure: ML-Scores as Surrogate Endpoints
timeFrame: 4 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS - Azienda ospedaliero-universitaria di Bologna
city: Bologna
country: Italy
facility: IRCCS - Azienda ospedaliero-universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Luciano Potena, MD
role: PRINCIPAL_INVESTIGATOR
References: