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.
Study Type
OBSERVATIONAL
Enrollment
30,000
Hôpital de la Pitié Salpêtrière
Paris, France
University Medical Center Saarland, Department of Internal Medicine II
Homburg, Saarland, Germany
Division of Gastroenterology, Department of Medical Sciences, University of Turin
Turin, Italy
Translational & Clinical Research Institute Faculty of Medical Sciences
Newcastle upon Tyne, United Kingdom
Major-adverse liver outcomes (MALO)
Development of cirrhosis. Hepatic decompensation: ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, portal hypertension, varices.
Time frame: 5 years follow-up time
All-cause mortality
Death during the follow-up period due to any cause
Time frame: 5 years follow-up time
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.
Time frame: 5 years
Assess prognostic biomarkers and develop a novel tool to integrate them into a digital tool to predict outcomes
Time frame: 5 years
Major adverse cardiac events (MACE)
Time frame: 5 years
Development of relevant clinical outcomes
Incidence of cancer, chronic kidney disease, neurodegenerative disease, dementia, and depression
Time frame: 5 years
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