Virtual twins could unlock secrets of fatty liver and heart risk
NCT ID NCT07430501
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to create detailed computer models, or 'virtual twins,' of people with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). By analyzing data from over 7,700 adults, researchers hope to better understand how the disease progresses and predict who might develop heart problems. The study is observational, meaning no treatment is given, and it focuses on gathering information to improve future care.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 7,720 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Vall d´Hebron Institute de Recerca (VHIR)
Barcelona, Barcelona, 08035, Spain
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