ALD - Alcoholic Liver Disease, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Steatotic Liver Disease, Steatotic Liver Disease of Mixed Origin (MetALD)
Conditions
Keywords
MASH, SLD, NITs, MASLD, ALD, MetALD, Metabolism, Liver
Brief summary
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.
Interventions
None listed
Sponsors
Universitatsmedizin Mainz - 1. Medizinische Klinik
Newcastle University
Barcelona Institute for Global Health
Odense University Hospital
Hospital Clinic of Barcelona
Assistance Publique - Hôpitaux de Paris
University of Turin, Italy
Universität des Saarlandes
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous Informed consent for cohort studies * \> 18 years of age * Diagnosis of SLD (MASLD, MetALD, ALD)
Exclusion criteria
* No consent for previous cohort studies * \< 18 years of age * No Diagnosis of SLD (MASLD, MetALD, ALD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major-adverse liver outcomes (MALO) | 5 years follow-up time | Development of cirrhosis. Hepatic decompensation: ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, portal hypertension, varices. |
| All-cause mortality | 5 years follow-up time | Death during the follow-up period due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life (HRQL) | 5 years | 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 | 5 years | — |
| Major adverse cardiac events (MACE) | 5 years | — |
| Development of relevant clinical outcomes | 5 years | Incidence of cancer, chronic kidney disease, neurodegenerative disease, dementia, and depression |
Countries
France, Germany, Italy, United Kingdom
Contacts
Primary ContactJörn M. Schattenberg, MD
Outcome results
None listed