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| Name | Class |
|---|---|
| Universitatsmedizin Mainz - 1. Medizinische Klinik | OTHER |
| Newcastle University | OTHER |
| Barcelona Institute for Global Health | OTHER |
| Odense University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| European SLD Registry | The EU-SLD registry comprises patients from 18 european countries and a study cohort of n=8.984 with most recent cases recruited in the prospective LITMUS cohort study. Now followed up as part of the LOVE Study in the EU-LIVERAIM project. |
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| Measure | Description | Time Frame |
|---|---|---|
| Major-adverse liver outcomes (MALO) | Development of cirrhosis. Hepatic decompensation: ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, portal hypertension, varices. | 5 years follow-up time |
| All-cause mortality | Death during the follow-up period due to any cause | 5 years follow-up time |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Assess prognostic biomarkers and develop a novel tool to integrate them into a digital tool to predict outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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European SLD register (historically EPOS, LITMUS); 18 european countries.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jörn M. Schattenberg, MD | Contact | +49684116 | 15027 | gastroenterologie@uks.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Pitié Salpêtrière | Paris | 75013 | France |
It is not yet known if there will be a plan to make IPD available.
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| OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Assistance Publique - Hôpitaux de Paris | OTHER |
| University of Turin, Italy | OTHER |
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serum
| 5 years |
| Major adverse cardiac events (MACE) | 5 years |
| Development of relevant clinical outcomes | Incidence of cancer, chronic kidney disease, neurodegenerative disease, dementia, and depression | 5 years |
| University Medical Center Saarland, Department of Internal Medicine II | Homburg | Saarland | 66421 | Germany |
| Division of Gastroenterology, Department of Medical Sciences, University of Turin | Turin | Italy |
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| Translational & Clinical Research Institute Faculty of Medical Sciences | Newcastle upon Tyne | NE2 4HH | United Kingdom |
|
| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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