Metabolic Dysfunction-Associated Steatotic Liver DiseaseARTEMISNCT07430501
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).
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Data recollection
- How many people
- 7,720 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2026to 2 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- - 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)
Show all 30Show fewer
- 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)
Who cannot join
- - 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.
Show all 36Show fewer
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Vall d´Hebron Institute de Recerca (VHIR)
Barcelona, Barcelona, 08035
About this study
Official title: 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.
Read the detailed description
- - Glossary CT : Computed Tomography CVD : Cardio-Vascular Disease HCC : Hepato Cellular Carcinoma MASH : Metabolic dysfunction-associated steatohepatitis MASLD : Metabolic dysfunction-Associated Steatotic Liver Disease MRI : Magnetic Resonance Imaging PET : Positron Emission Tomography SLD : Steatotic Liver Disease TACE : Trans-Arterial ChemoEmbolisation TARE : Trans-Arterial RadioEmbolisation TIPS : Transjugular Intrahepatic Portosystemic Shunt US : Ultrasound USE : Ultrasound elastography VCTE : Vibration-Controlled Transient Elastography
- - 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:
- To develop and validate machine-learning or mechanistic models that can predict the evolution of liver diseases, in particular MASLD at various stages (use cases 1 and 2), and the outcome of some intervention or therapies (use cases 3 and 4).
- To identify new correlations or validate suspected correlations between specific observations, interventions and outcomes, in particular cardiovascular complications.
- - 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.
- - Objective(s) of the clinical study
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.
- Being tested
- Data recollection
- Keywords
- MASLD, Virtual twins, fatty liver patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data recollectionOther
Only data recollection for their use in the training, testing and early validation of computational models (but no other intervention) will be performed.
| Study group | Role | What they receive |
|---|---|---|
| ARTEMIs cohort | * 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. Receives: Other: Data recollection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline assessment to last available follow-up (minimum 1 year, up to 5 years)
Secondary outcomes (1)
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.
Measured: Up to 5 years after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start23 Feb 2026 (estimated)
- Primary completion2 Jun 2026 (estimated)
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Matical Innovation SL, Assistance Publique - Hôpitaux de Paris, Jena University Hospital, Institut National de Recherche en Informatique et en Automatique, German Cancer Research Center, MEDEX, European Liver Patients' Association, Betthera s.r.o., Bournemouth University, University Hospital Heidelberg, Fundacion Para La Investigacion Hospital La Fe, University of Roma La Sapienza, Charite University, Berlin, Germany, Medical University of Vienna, Saint-Luc University Hospital, University of Freiburg, University of Leipzig, Sheba Medical Center, Imperial College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430501
- Sponsor's protocol ID
- ARTEMIS_HE-HLTH2023
- Other IDs
- 101136299
- Acronym
- ARTEMIS
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cui TM, Liu Y, Wang JB, Liu LX. Adverse Effects of Immune-Checkpoint Inhibitors in Hepatocellular Carcinoma. Onco Targets Ther. 2020 Nov 16;13:11725-11740. doi: 10.2147/OTT.S279858. eCollection 2020.
PubMed 33235462Porcu M, De Silva P, Solinas C, Battaglia A, Schena M, Scartozzi M, Bron D, Suri JS, Willard-Gallo K, Sangiolo D, Saba L. Immunotherapy Associated Pulmonary Toxicity: Biology Behind Clinical and Radiological Features. Cancers (Basel). 2019 Mar 5;11(3):305. doi: 10.3390/cancers11030305.
PubMed 30841554Shalata W, Abu-Salman A, Steckbeck R, Mathew Jacob B, Massalha I, Yakobson A. Cardiac Toxicity Associated with Immune Checkpoint Inhibitors: A Systematic Review. Cancers (Basel). 2021 Oct 18;13(20):5218. doi: 10.3390/cancers13205218.
PubMed 34680365Chung WB, Youn JC, Youn HJ. Cardiovascular Complications of Novel Anti-Cancer Immunotherapy: Old Problems from New Agents? Korean Circ J. 2020 Sep;50(9):743-753. doi: 10.4070/kcj.2020.0158. Epub 2020 May 27.
PubMed 32725983Liu KL, Chen JS, Chen SC, Chu PH. Cardiovascular Toxicity of Molecular Targeted Therapy in Cancer Patients: A Double-Edged Sword. Acta Cardiol Sin. 2013 Jul;29(4):295-303.
PubMed 27122721Llovet JM, Castet F, Heikenwalder M, Maini MK, Mazzaferro V, Pinato DJ, Pikarsky E, Zhu AX, Finn RS. Immunotherapies for hepatocellular carcinoma. Nat Rev Clin Oncol. 2022 Mar;19(3):151-172. doi: 10.1038/s41571-021-00573-2. Epub 2021 Nov 11.
PubMed 34764464Ali SA, Arman HE, Shamseddeen H, Elsner N, Elsemesmani H, Johnson S, Zenisek J, Khemka A, Jarori U, Patidar KR, Orman E, Kubal C, Frick K. Cirrhotic cardiomyopathy: Predictors of major adverse cardiac events and assessment of reversibility after liver transplant. J Cardiol. 2023 Aug;82(2):113-121. doi: 10.1016/j.jjcc.2023.04.007. Epub 2023 Apr 20.
PubMed 37085028Qureshi W, Mittal C, Ahmad U, Alirhayim Z, Hassan S, Qureshi S, Khalid F. Clinical predictors of post-liver transplant new-onset heart failure. Liver Transpl. 2013 Jul;19(7):701-10. doi: 10.1002/lt.23654. Epub 2013 Jun 3.
PubMed 23554120Snowden CP, Hughes T, Rose J, Roberts DR. Pulmonary edema in patients after liver transplantation. Liver Transpl. 2000 Jul;6(4):466-70. doi: 10.1053/jlts.2000.7580.
PubMed 10915170Mohammadi F, Ramachandran J, Woodman R, Muller K, John L, Chen J, Wigg A. Impact of cardiac dysfunction on morbidity and mortality in liver transplant candidates. Clin Transplant. 2022 Jul;36(7):e14682. doi: 10.1111/ctr.14682. Epub 2022 May 16.
PubMed 35441375Sonny A, Govindarajan SR, Jaber WA, Cywinski JB. Systolic heart failure after liver transplantation: Incidence, predictors, and outcome. Clin Transplant. 2018 Mar;32(3):e13199. doi: 10.1111/ctr.13199. Epub 2018 Feb 1.
PubMed 29323769Rajesh S, George T, Philips CA, Ahamed R, Kumbar S, Mohan N, Mohanan M, Augustine P. Transjugular intrahepatic portosystemic shunt in cirrhosis: An exhaustive critical update. World J Gastroenterol. 2020 Oct 7;26(37):5561-5596. doi: 10.3748/wjg.v26.i37.5561.
PubMed 33088154Modha K, Kapoor B, Lopez R, Sands MJ, Carey W. Symptomatic Heart Failure After Transjugular Intrahepatic Portosystemic Shunt Placement: Incidence, Outcomes, and Predictors. Cardiovasc Intervent Radiol. 2018 Apr;41(4):564-571. doi: 10.1007/s00270-017-1848-1. Epub 2017 Nov 27.
PubMed 29181605Ali A, Sarwar A, Patwardhan VR, Fraiche AM, Tahir MM, Luo M, Weinstein JL, Hussain MS, Curry MP, Ahmed M. Echocardiographic and Other Preprocedural Predictors of Heart Failure After TIPS Placement in Patients With Cirrhosis: A Single-Center 15-Year Analysis. AJR Am J Roentgenol. 2022 Jul;219(1):110-118. doi: 10.2214/AJR.21.26947. Epub 2022 Feb 16.
PubMed 35170360Billey C, Billet S, Robic MA, Cognet T, Guillaume M, Vinel JP, Peron JM, Lairez O, Bureau C. A Prospective Study Identifying Predictive Factors of Cardiac Decompensation After Transjugular Intrahepatic Portosystemic Shunt: The Toulouse Algorithm. Hepatology. 2019 Dec;70(6):1928-1941. doi: 10.1002/hep.30934.
PubMed 31512743
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcceleRating the Translation of Virtual Twins Towards a pErsonalised Management of Steatotic Liver Patients
- ClinicalTrials.gov ID
- NCT07430501
- Acronym / sponsor ID
- ARTEMIS / ARTEMIS_HE-HLTH2023
- Keywords
- MASLD, Virtual twins, fatty liver patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,720 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Matical Innovation SL, Assistance Publique - Hôpitaux de Paris, Jena University Hospital, Institut National de Recherche en Informatique et en Automatique, German Cancer Research Center, MEDEX, European Liver Patients' Association, Betthera s.r.o., Bournemouth University, University Hospital Heidelberg, Fundacion Para La Investigacion Hospital La Fe, University of Roma La Sapienza, Charite University, Berlin, Germany, Medical University of Vienna, Saint-Luc University Hospital, University of Freiburg, University of Leipzig, Sheba Medical Center, Imperial College London
- Study start
- 23 Feb 2026 (estimated)
- Primary completion
- 2 Jun 2026 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- - Glossary CT : Computed Tomography CVD : Cardio-Vascular Disease HCC : Hepato Cellular Carcinoma MASH : Metabolic dysfunction-associated steatohepatitis MASLD : Metabolic dysfunction-Associated Steatotic Liver Disease MRI : Magnetic Resonance Imaging PET : Positron Emission Tomography SLD : Steatotic Liver Disease TACE : Trans-Arterial ChemoEmbolisation TARE : Trans-Arterial RadioEmbolisation TIPS : Transjugular Intrahepatic Portosystemic Shunt US : Ultrasound USE : Ultrasound elastography VCTE : Vibration-Controlled Transient Elastography
- - 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:
- To develop and validate machine-learning or mechanistic models that can predict the evolution of liver diseases, in particular MASLD at various stages (use cases 1 and 2), and the outcome of some intervention or therapies (use cases 3 and 4).
- To identify new correlations or validate suspected correlations between specific observations, interventions and outcomes, in particular cardiovascular complications.
- - 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.
- - Objective(s) of the clinical study
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARTEMIs cohort | – | Other: Data recollection* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (30 listed)
- - 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.
- Age ≥18 years
- TIPS indication (Baveno VII), except pre-emptive and salvage TIPS.
Key exclusion criteria (36 listed)
- - 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.
- Non-cirrhosis TIPS
- Portosinusoidal vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data recollectionOnly data recollection for their use in the training, testing and early validation of computational models (but no other intervention) will be performed. | Other | ARTEMIs cohort |
Primary outcome
Liver disease progression and regression in MASLD patients
Time frame: From baseline assessment to last available follow-up (minimum 1 year, up to 5 years)
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
1 secondary outcome
Incidence of cardiovascular events in MASLD patients
Time frame: Up to 5 years after baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 33235462Cui TM, Liu Y, Wang JB, Liu LX. Adverse Effects of Immune-Checkpoint Inhibitors in Hepatocellular Carcinoma. Onco Targets Ther. 2020 Nov 16;13:11725-11740. doi: 10.2147/OTT.S279858. eCollection 2020.
- Background: PubMed 30841554Porcu M, De Silva P, Solinas C, Battaglia A, Schena M, Scartozzi M, Bron D, Suri JS, Willard-Gallo K, Sangiolo D, Saba L. Immunotherapy Associated Pulmonary Toxicity: Biology Behind Clinical and Radiological Features. Cancers (Basel). 2019 Mar 5;11(3):305. doi: 10.3390/cancers11030305.
- Background: PubMed 34680365Shalata W, Abu-Salman A, Steckbeck R, Mathew Jacob B, Massalha I, Yakobson A. Cardiac Toxicity Associated with Immune Checkpoint Inhibitors: A Systematic Review. Cancers (Basel). 2021 Oct 18;13(20):5218. doi: 10.3390/cancers13205218.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Raul Herance, PhD (937372444 ext. 9344, raul.herance@vhir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver disease progression and regression in MASLD patients (time frame: From baseline assessment to last available follow-up (minimum 1 year, up to 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430501, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.