Artificial Intelligence (AI)DARENCT06774768
Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients
An observational study of Artificial Intelligence (AI) and Hepatocellular Carcinoma (HCC), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artificial Intelligence (AI), Hepatocellular Carcinoma (HCC), Heart Transplantation
- How many people
- 1,000 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Jan 2025to 31 Dec 2029
- Phase
- Observational
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: 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.
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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
IRCCS - Azienda ospedaliero-universitaria di Bologna
Bologna, 40138
Luciano Potena, MD, 0512143725, scompenso.trapiantocuore@aosp.bo.it
IRCCS - Azienda ospedaliero-universitaria di Bologna
Bologna, 40138
Maria Cristina Morelli, MD, 0512144248, mariacristina.morelli@aosp.bo.it
About this study
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.
Read the 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.
- Conditions
- Artificial Intelligence (AI), Hepatocellular Carcinoma (HCC), Heart Transplantation, Liver Transplantation, Machine Learning, Major Cardiovascular Event
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
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.
Measured: 4 years
Major Cardiovascular Event (MACE)
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
Measured: 4 years
New onset malignancy
New onset malignancy, defined as hematopoietic or solid malignant neoplasm, developing after transplantation
Measured: 4 years
Chronic graft dysfunction
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.
Measured: 4 years
Secondary outcomes (1)
ML-Scores as Surrogate Endpoints
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Intelligence (AI)Studies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciano Potena, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774768
- Sponsor's protocol ID
- DARE
- Other IDs
- PNC0000002 3000435
- Acronym
- DARE
- Status last verified
- Dec 2024
- First submitted
- 9 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No