An observational study in Metabolic Dysfunction-Associated Steatotic Liver Disease, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational
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.
- Description of the Clininical Study
ARTEMIs retrospective cohort responds to the definition of a "retrospective collection and analysis of health data obtained from individual patients or healthy persons in order to address scientific questions related to the understanding, prevention, diagnosis, monitoring or treatment of a disease, mental illness, or physical condition" as defined in the work programme of this call. In such, the definition of a clinical study as defined by Regulation 536/2014 (on medicinal products) is not applicable in the framework of our study.
The cohort will serve the following main objectives:
- Study rationale Metabolic dysfunction-associated steatotic liver disease (MASLD) is presently the most common chronic liver disease worldwide, accounting for a global prevalence of 25.24% (2). Its natural history remains unclear, given the multiple pathways through which disease progression takes place (3), as well as to the shortage of population-based studies addressing its long-term prognosis (4). As an attempt to alleviate the paucity of good quality data on MASLD's natural history (5) and to improve patient's care, the ARTEMIS project envisages to constitute a longitudinal cohort comprising patients at various stages of liver diseases, with emphasis on MASLD (use cases 1 and 2).
Given the remarkable heterogeneity underlying MASLD mechanisms, the deployment of computational models has increased in popularity among the scientific community, as an effective means to unravel this intricate subject (6). In particular, the understanding of the human liver metabolism plays a key role towards a deeper understanding of the main drivers that rule disease progression. In such, mechanistic models play a major role in the representation of the complexity that is inherent to the liver and the gastroenterology system. In a complementary way, machine learning models are expected to respond to more precise questions related to different stages of the disease and related comorbidities, therefore allowing the prediction of diagnosis and prognosis, as well as risk stratification, based upon parameters that are specific to each subpopulation.
In this light, the ARTEMIS cohort will be used to test new hypotheses, as well as to train, validate and evaluate the performance of computational models - including machine-learning models, mechanistic models and associations thereof - aimed to improve the management of MASLD patients. The ARTEMIs cohort will incorporate retrospective multisource data for MASLD patients along the spectrum of the disease, thus including MASH, cirrhosis and HCC patients. The cohort will include patients from 12 centres in 7 countries. The cohort will also incorporate data related to the most relevant comorbidities associated with these populations, most notably, cardiovascular events.
- Extent and evaluation of current knowledge directly linked to the scientific question(s) to be answered by the clinical study
In addition to the complexities concerning its natural history, MASLD has been associated with an increased risk of developing cardiovascular disease (CVD) and cardiac events, including coronary artery disease, atherosclerosis, heart failure, and arrhythmia. The exact mechanism by which MASLD increases the risk of CVD is not fully understood, but it is thought to be related to the systemic inflammation and metabolic dysfunction associated with the condition.
Several studies have investigated the relationship between MASLD and cardiac events. A systematic review and meta-analysis published in 2016 (7), analysed 16 prospective and retrospective cohorts with 34,043 adult individuals (36.3% with MASLD) and approximately 2,600 CVD outcomes (>70% CVD deaths) over a median period of 6.9 years. They concluded that MASLD is associated with an increased risk of fatal and non-fatal CVD events, although the design of the observational studies did not allow to draw definitive causal inferences.
There is a consensus that MASLD patients should be closely monitored for cardiovascular risk factors and managed accordingly to reduce their risk of developing CVD. Nevertheless, given the high current prevalence of the disease and its expected growth, such monitoring may enormously stress the public healthcare systems.
Solutions that help to stratify those MASLD patients at higher risk of suffering cardiovascular events, are needed. The ARTEMIs cohort is aimed to assist the development of this type of solutions, based on advanced computational models.
The ARTEMIs project envisages to consolidate a holistic virtual model allowing, on the one hand, a better understanding of the underlying mechanisms involved in MASLD progression, as well as the prediction of cardiovascular events at different stages of the disease. In this light, 4 clinical cases will be considered, wherein theory-based mechanistic and data-driven AI models will be developed and validated, either individually or in association, depending on the clinical questions being raised.
The objective of ARTEMIs cohort is to assess the performance of mechanistic and AI-based models that will be deployed in the different clinical cases, based on their respective sensibility and specificity.
Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
- 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.
- Clinical Use case 2: MASLD and progression of cardiovascular diseases
3.1- Clinical Use case 3-TIPS: Patients with cirrhosis and portal hypertension who receive TIPS placement.
3.2.- Clinical Use Case 3-LT: Patients with cirrhosis and portal hypertension who received liver transplantation.
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)
With a minimum follow-up of two years or until death, after diagnosis of HCC
5.- Other populations (participation in control arms)
EXCLUSION CRITERIA:
- 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.
- Clinical Use case 2: MASLD and progression of cardiovascular diseases
3.1- Clinical Use case 3-TIPS: Patients with cirrhosis and portal hypertension who receive TIPS placement.
3.2.- Clinical Use Case 3-LT: Patients with cirrhosis and portal hypertension who received liver transplantation.
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)
Subjects with diagnosis of tumor of mixed origin, either from radiological or biopsy report.
5.- Other populations (participation in control arms)
* 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
Only data recollection for their use in the training, testing and early validation of computational models (but no other intervention) will be performed.
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
Time frame: From baseline assessment to last available follow-up (minimum 1 year, up to 5 years)
Incidence of cardiovascular events in MASLD patients
Occurrence of cardiovascular events including myocardial infarction, stroke, atrial fibrillation, and heart failure in MASLD patients during retrospective follow-up.
Time frame: Up to 5 years after baseline assessment
Cardiovascular complications following TIPS placement or liver transplantation
Incidence of cardiac events, including heart failure, myocardial infarction, symptomatic coronary heart disease, and arrhythmias, in patients with cirrhosis undergoing TIPS placement or liver transplantation.
Time frame: From intervention to 1 year (TIPS) and up to 5 years (liver transplantation)
Cardiac complications associated with hepatocellular carcinoma treatments
Occurrence of cardiac-related adverse events following surgical, locoregional, or systemic treatments for hepatocellular carcinoma
Time frame: Up to 2 years after HCC treatment
Plan to share: No
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Hospital Universitari Vall d'Hebron Research Institute