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).

A vizsgálat adatai

Ki végzi

Hospital Universitari Vall d'Hebron Research Institute

Azonosító

NCT07430501

A regiszteradat frissítve

2026. február 24.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: - 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).

Kizáró feltételek: 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