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).

NCT07430501 | Not Yet Recruiting DMC

• 2 other identifiers: ARTEMIS_HE-HLTH2023101136299
• Study Type: observational
• Target: 7,720
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

MASLD; Virtual twins; fatty liver patients

Outcome Measures

Primary Outcomes (1)

• Liver disease progression and regression in MASLD patients

  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 Outcomes (1)

• Incidence of cardiovascular events in MASLD patients

  Up to 5 years after baseline assessment

Other Outcomes (2)

• Cardiovascular complications following 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

  Up to 2 years after HCC treatment

Study Arms (1)

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

Interventions

Data recollection OTHER

Only data recollection for their use in the training, testing and early validation of computational models (but no other intervention) will be performed.

ARTEMIs cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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
• \- 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
• 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.

You may not qualify if:

• \- 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.
• \- 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Vall d´Hebron Institute de Recerca (VHIR)

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (29)

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Biospecimen

Retention: SAMPLES WITH DNA

Retrospectively collected biospecimens stored in existing biobanks at participating centers, including liver tissue samples, whole blood, serum, and plasma. Biospecimens are collected as part of routine clinical care or previous cohorts and are reused for secondary analyses such as proteomics, metabolomics, and lipidomics. No new biospecimen collection is performed as part of this observational study.

Central Study Contacts

Jose Raul Herance, PhD

CONTACT

937372444; raul.herance@vhir.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 24, 2026
• Study Start: February 23, 2026
• Primary Completion: June 2, 2026
• Study Completion (Estimated): September 2, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)