The rational to conduct the LOVE study builds on the lack of available data on outcomes in steatotic liver disease in well characterized patients over a time frame of several years. At current limited data on liver-specific and overall outcome in patients with MASLD, MetALD and ALD are available. Liver histology is the only accepted surrogate to reasonably likely predict outcomes in patients with non-cirrhotic liver disease and is currently used in regulatory trials. To overcome the limitations of liver biopsy and use validated non-invasive tests (NITs) to predict outcomes, the LOVE study will be conducted based on existing cohort studies in well pheno- and genotyped patients and will inform on the relevant outcomes based on baseline and ongoing biomarker assessment. The overarching goal is to qualify a NIT for patient identification and preventive measures in the regulatory context.
Previous Informed consent for cohort studies
> 18 years of age
Diagnosis of SLD (MASLD, MetALD, ALD)
No consent for previous cohort studies
< 18 years of age
No Diagnosis of SLD (MASLD, MetALD, ALD)
European SLD register (historically EPOS, LITMUS); 18 european countries. https://pubmed.ncbi.nlm.nih.gov/33045403/
Cohort
Cross-sectional
Not listed
Major-adverse liver outcomes (MALO)
Development of cirrhosis. Hepatic decompensation: ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, portal hypertension, varices.
All-cause mortality
Death during the follow-up period due to any cause
Health-related quality of life (HRQL)
To measure the impact on the health-related quality of life in patients during the natural history of the disease.
Assess prognostic biomarkers and develop a novel tool to integrate them into a digital tool to predict outcomes
Major adverse cardiac events (MACE)
Development of relevant clinical outcomes
Incidence of cancer, chronic kidney disease, neurodegenerative disease, dementia, and depression
Click on the lead sponsor to view all of their trials.
Universität des Saarlandes
Lead sponsor
Universitatsmedizin Mainz - 1. Medizinische Klinik
Collaborator
Newcastle University
Collaborator
Barcelona Institute for Global Health
Collaborator
Odense University Hospital
Collaborator
Hospital Clinic of Barcelona
Collaborator
Assistance Publique - Hôpitaux de Paris
Collaborator
University of Turin, Italy
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
