Building virtual models to understand fatty liver disease and predict heart problems

Trial details

Who runs it

Hospital Universitari Vall d'Hebron Research Institute

Trial code

NCT07430501

Record updated

24 February 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: - 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; 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: Patients with surgical porto-caval shunts; 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; Fully recovered from any prior surgery and/or radiation and none within 2 weeks of initiating treatment; - 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; Portosinusoidal vascular disease; Complete portal vein thrombosis; 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 who were transplanted due to acute liver failure; 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); Uncontrolled inter-current illness or psychiatric illness or social situations that would limit compliance with study requirements; Subjects with history of another primary cancer; Subjects with active hepatitis B or C on antiviral compounds may remain on such treatment, except for interferon; - 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; Non-cirrhosis TIPS; Patients who were already transplanted before (retransplant); Mixed-tumor HCC based on radiological and/or pathological examination; 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.

ClinicalTrials.gov NCT07430501