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).
Starting soon
Conditions studied: Metabolic Dysfunction-Associated Steatotic Liver Disease
In brief
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.
Key facts
- Study ID
- NCT07430501
- Run by
- Hospital Universitari Vall d'Hebron Research Institute
- People needed
- 7720
- Starts
- 2026-02-23
- Expected to finish
- 2027-09-02
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
- 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.
- 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
- - 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
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
- 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
- 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.
Where it is running
- Vall d´Hebron Institute de Recerca (VHIR) — Barcelona, Barcelona, Spain
Full record on ClinicalTrials.gov
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