Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)

Not yet recruiting

• Conditions: Steatotic Liver Disease; MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis); Steatotic Liver Disease of Mixed Origin (MetALD); ALD - Alcoholic Liver Disease

• Registration Number: NCT06907563
• Lead Sponsor: Universität des Saarlandes

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Study Start: 2025-04-15
• Primary Completion: 2030-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

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

Hôpital de la Pitié Salpêtrière; 🇫🇷 Paris, France

University Medical Center Saarland, Department of Internal Medicine II; 🇩🇪 Homburg, Saarland, Germany