Using Digital Twin Technology and Clinical Decision Support Systems to Improve the Early Detection, Personalised Treatment, and Long-term Monitoring of Patients Across the Full Spectrum of Metabolic-associated Fatty Liver Disease (MAFLD). (ARTEMIS)

February 17, 2026 updated by: Hospital Universitari Vall d'Hebron Research Institute

AcceleRating the Translation of Virtual Twins Towards a pErsonalised Management of Steatotic Liver Patients

The goal of this observational study is to create a detailed virtual model to better understand how Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) develops. This model will also help predict heart problem at different stage of the disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. - Glossary CT : Computed Tomography CVD : Cardio-Vascular Disease HCC : Hepato Cellular Carcinoma MASH : Metabolic dysfunction-associated steatohepatitis MASLD : Metabolic dysfunction-Associated Steatotic Liver Disease MRI : Magnetic Resonance Imaging PET : Positron Emission Tomography SLD : Steatotic Liver Disease TACE : Trans-Arterial ChemoEmbolisation TARE : Trans-Arterial RadioEmbolisation TIPS : Transjugular Intrahepatic Portosystemic Shunt US : Ultrasound USE : Ultrasound elastography VCTE : Vibration-Controlled Transient Elastography

  2. - Description of the Clininical Study

    ARTEMIs retrospective cohort responds to the definition of a "retrospective collection and analysis of health data obtained from individual patients or healthy persons in order to address scientific questions related to the understanding, prevention, diagnosis, monitoring or treatment of a disease, mental illness, or physical condition" as defined in the work programme of this call. In such, the definition of a clinical study as defined by Regulation 536/2014 (on medicinal products) is not applicable in the framework of our study.

    The cohort will serve the following main objectives:

    • To develop and validate machine-learning or mechanistic models that can predict the evolution of liver diseases, in particular MASLD at various stages (use cases 1 and 2), and the outcome of some intervention or therapies (use cases 3 and 4).
    • To identify new correlations or validate suspected correlations between specific observations, interventions and outcomes, in particular cardiovascular complications.

  3. - Study rationale Metabolic dysfunction-associated steatotic liver disease (MASLD) is presently the most common chronic liver disease worldwide, accounting for a global prevalence of 25.24% (2). Its natural history remains unclear, given the multiple pathways through which disease progression takes place (3), as well as to the shortage of population-based studies addressing its long-term prognosis (4). As an attempt to alleviate the paucity of good quality data on MASLD's natural history (5) and to improve patient's care, the ARTEMIS project envisages to constitute a longitudinal cohort comprising patients at various stages of liver diseases, with emphasis on MASLD (use cases 1 and 2).

    Given the remarkable heterogeneity underlying MASLD mechanisms, the deployment of computational models has increased in popularity among the scientific community, as an effective means to unravel this intricate subject (6). In particular, the understanding of the human liver metabolism plays a key role towards a deeper understanding of the main drivers that rule disease progression. In such, mechanistic models play a major role in the representation of the complexity that is inherent to the liver and the gastroenterology system. In a complementary way, machine learning models are expected to respond to more precise questions related to different stages of the disease and related comorbidities, therefore allowing the prediction of diagnosis and prognosis, as well as risk stratification, based upon parameters that are specific to each subpopulation.

    In this light, the ARTEMIS cohort will be used to test new hypotheses, as well as to train, validate and evaluate the performance of computational models - including machine-learning models, mechanistic models and associations thereof - aimed to improve the management of MASLD patients. The ARTEMIs cohort will incorporate retrospective multisource data for MASLD patients along the spectrum of the disease, thus including MASH, cirrhosis and HCC patients. The cohort will include patients from 12 centres in 7 countries. The cohort will also incorporate data related to the most relevant comorbidities associated with these populations, most notably, cardiovascular events.

  4. - Extent and evaluation of current knowledge directly linked to the scientific question(s) to be answered by the clinical study

    In addition to the complexities concerning its natural history, MASLD has been associated with an increased risk of developing cardiovascular disease (CVD) and cardiac events, including coronary artery disease, atherosclerosis, heart failure, and arrhythmia. The exact mechanism by which MASLD increases the risk of CVD is not fully understood, but it is thought to be related to the systemic inflammation and metabolic dysfunction associated with the condition.

    Several studies have investigated the relationship between MASLD and cardiac events. A systematic review and meta-analysis published in 2016 (7), analysed 16 prospective and retrospective cohorts with 34,043 adult individuals (36.3% with MASLD) and approximately 2,600 CVD outcomes (>70% CVD deaths) over a median period of 6.9 years. They concluded that MASLD is associated with an increased risk of fatal and non-fatal CVD events, although the design of the observational studies did not allow to draw definitive causal inferences.

    There is a consensus that MASLD patients should be closely monitored for cardiovascular risk factors and managed accordingly to reduce their risk of developing CVD. Nevertheless, given the high current prevalence of the disease and its expected growth, such monitoring may enormously stress the public healthcare systems.

    Solutions that help to stratify those MASLD patients at higher risk of suffering cardiovascular events, are needed. The ARTEMIs cohort is aimed to assist the development of this type of solutions, based on advanced computational models.

  5. - Objective(s) of the clinical study

The ARTEMIs project envisages to consolidate a holistic virtual model allowing, on the one hand, a better understanding of the underlying mechanisms involved in MASLD progression, as well as the prediction of cardiovascular events at different stages of the disease. In this light, 4 clinical cases will be considered, wherein theory-based mechanistic and data-driven AI models will be developed and validated, either individually or in association, depending on the clinical questions being raised.

The objective of ARTEMIs cohort is to assess the performance of mechanistic and AI-based models that will be deployed in the different clinical cases, based on their respective sensibility and specificity.

Study Type

Observational

Enrollment (Estimated)

7720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08035
        • Vall d´Hebron Institute de Recerca (VHIR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population description involve a retrospective collection and analysis of health data obtained from individual patients or healthy persons. Patients along the MASLD spectrum will be recruited in 12 participant sites. A researcher will select cases fulfilling the inclusion and exclusion criteria and process them according to the Project work plan.

Description

INCLUSION CRITERIA:

  1. - Clinical Use Case 1: Liver disease staging in MASLD patients - Prediction model of fibrosis changes (progression and regression), with ability to distinguish between fast and non-fast fibrosis progression among MASLD patients.

    • Age ≥18 years
    • Diagnosis of MASLD confirmed by radiological imaging (any type: MR, CT, PET, VCTE, US, USE...) or histology (gold standard, following MASH SAF score)
    • With at least one follow-up of minimum 1 year after diagnosis of MASLD, with radiological imaging or histology

  2. - Clinical Use case 2: MASLD and progression of cardiovascular diseases

    • Age ≥18 years MASLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)
    • Patients without known heart disease
    • Cardiovascular assessment available

3.1- Clinical Use case 3-TIPS: Patients with cirrhosis and portal hypertension who receive TIPS placement.

  • Age ≥18 years
  • TIPS indication (Baveno VII), except pre-emptive and salvage TIPS.
  • Recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods
  • Refractory or recurrent ascites or difficult to treat
  • Refractory Hydrothorax
  • Patients with diagnosis of liver cirrhosis (based on laboratory parameters, clinical, endoscopic, radiological or histological findings), of any aetiology.

3.2.- Clinical Use Case 3-LT: Patients with cirrhosis and portal hypertension who received liver transplantation.

  • Age ≥18 years

  • All patients with cirrhosis (all aetiologies) who were transplanted

    4.- Clinical Use Case 4: Prediction of cardiac complications due to HCC treatments* (*Note: includes surgical interventions, ablation, TACE, TARE, SIRT and immunotherapies)

  • Age ≥18 years
  • Diagnosis of HCC (any aetiology)
  • Cross sectional imaging follow-up (any modality) of liver diseases 6 months after treatment
  • Non-cirrhotic or no more than Child-Pugh B cirrhosis.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients without history of prior HCC
  • Patients with a history of hypertension should be well controlled (< 140/90 mmHg) on a regimen of antihypertensive therapy.

  • With a minimum follow-up of two years or until death, after diagnosis of HCC

    5.- Other populations (participation in control arms)

  • Age ≥18 years
  • Subjects presenting cardiac fibrosis, without a known MASLD diagnosis (as controls for use case 2)

EXCLUSION CRITERIA:

  1. - Clinical Use Case 1: Liver disease staging in MASLD patients - Prediction model of fibrosis changes (progression and regression), with ability to distinguish between fast and non-fast fibrosis progression among MASLD patients.

    • Missing data on blood glucose, BMI and metabolic status.
    • Patients who have received systemic chemotherapy
    • Patients with hepatitis B (HBV) and hepatitis C (HCV), alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 30g / D in male and ≥ 20g / D in female), drug-induced liver disease or autoimmune hepatitis.
    • Subjects having a significant risk of bleeding (platelet < 50x109 / L, prothrombin activity < 50%)
    • Presence of any other form of chronic liver, at the time of MASLD diagnosis.

  2. - Clinical Use case 2: MASLD and progression of cardiovascular diseases

    • Association with another cause of liver disease
    • History of hepatitis B or C
    • Already known coronary artery disease
    • History of cardiovascular events

3.1- Clinical Use case 3-TIPS: Patients with cirrhosis and portal hypertension who receive TIPS placement.

  • Non-cirrhosis TIPS
  • Portosinusoidal vascular disease
  • Complete portal vein thrombosis
  • Patients with surgical porto-caval shunts.
  • Patients with evidence of current locally advanced or metastatic malignancy
  • Patients with acute or chronic heart failure (New York Heart Association [NYHA]).
  • Patients with chronic obstructive pulmonary disease GOLD grade III/IV
  • Patients with chronic kidney disease requiring renal replacement therapy
  • Patients with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection
  • Patients with previous liver transplantation
  • Patients lost to follow-up and therefore have an incomplete 1-year follow-up

3.2.- Clinical Use Case 3-LT: Patients with cirrhosis and portal hypertension who received liver transplantation.

  • Patients who were transplanted due to acute liver failure.
  • Patients who were already transplanted before (retransplant)

  • Patients who are lost to follow-up in the first 5 years after liver transplant.

    4.- Clinical Use Case 4: Prediction of cardiac complications due to HCC treatments* (*Note: includes surgical interventions, ablation, TACE, TARE, SIRT and immunotherapies)

  • Mixed-tumor HCC based on radiological and/or pathological examination
  • Uncontrolled inter-current illness or psychiatric illness or social situations that would limit compliance with study requirements.
  • Subjects with history of another primary cancer
  • Fully recovered from any prior surgery and/or radiation and none within 2 weeks of initiating treatment.
  • Subjects with active hepatitis B or C on antiviral compounds may remain on such treatment, except for interferon.

  • Subjects with diagnosis of tumor of mixed origin, either from radiological or biopsy report.

    5.- Other populations (participation in control arms)

  • Patients with diagnosis of MASLD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARTEMIs cohort
  • Clinical Use Case #1& 2: Adult patients diagnosed with MASLD/MASH. Clinical Use Case #2, subgroup of patients with cardiovascular disease: Adult patients diagnosed with cardiac fibrosis, with or without MASLD.
  • Clinical Use Case #3: Adult patients diagnosed with cirrhosis.
  • Clinical Use Case #4: Adult patients diagnosed with HCC.
  • Control group: Adult patients with neither liver conditions nor cardiovascular events, as healthy control for the ARTEMIs models.
Other: Data recollection
Only data recollection for their use in the training, testing and early validation of computational models (but no other intervention) will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver disease progression and regression in MASLD patients
Time Frame: From baseline assessment to last available follow-up (minimum 1 year, up to 5 years)
Probability rates of liver disease progression or regression in MASLD patients, including fibrosis stage changes and development of steatohepatitis (MASH), assessed using validated non-invasive tests, imaging techniques, and liver histology when available
From baseline assessment to last available follow-up (minimum 1 year, up to 5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cardiovascular events in MASLD patients
Time Frame: Up to 5 years after baseline assessment
Occurrence of cardiovascular events including myocardial infarction, stroke, atrial fibrillation, and heart failure in MASLD patients during retrospective follow-up.
Up to 5 years after baseline assessment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular complications following TIPS placement or liver transplantation
Time Frame: From intervention to 1 year (TIPS) and up to 5 years (liver transplantation)
Incidence of cardiac events, including heart failure, myocardial infarction, symptomatic coronary heart disease, and arrhythmias, in patients with cirrhosis undergoing TIPS placement or liver transplantation.
From intervention to 1 year (TIPS) and up to 5 years (liver transplantation)
Cardiac complications associated with hepatocellular carcinoma treatments
Time Frame: Up to 2 years after HCC treatment
Occurrence of cardiac-related adverse events following surgical, locoregional, or systemic treatments for hepatocellular carcinoma
Up to 2 years after HCC treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Assistance Publique - Hôpitaux de Paris
Medical University of Vienna
Charite University, Berlin, Germany
University of Roma La Sapienza
Imperial College London
University of Leipzig
German Cancer Research Center
Sheba Medical Center
University Hospital Heidelberg
Jena University Hospital
MEDEX
University of Freiburg
Bournemouth University
Fundacion Para La Investigacion Hospital La Fe
Saint-Luc University Hospital
EUROPEAN LIVER PATIENTS ASSOCIATION
Betthera s.r.o.
Matical Innovation SL
Institut National de Recherche en Informatique et Automatique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 23, 2026

Primary Completion (Estimated)

June 2, 2026

Study Completion (Estimated)

September 2, 2027

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARTEMIS_HE-HLTH2023
  • 101136299 (Other Grant/Funding Number: Horizon Europe | RIA (Topic HORIZON-HLTH-2023-TOOL-05-03))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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