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

NCT06907563 | Not Yet Recruiting DMC

• 1 other identifier: LOVE study
• Study Type: observational
• Target: 30,000
• Locations: 4 countries
• Sites: 4

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.

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

Keywords

MASH; SLD; NITs; MASLD; ALD; MetALD; Metabolism; Liver

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Health-related quality of life (HRQL)

  5 years

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

European SLD register (historically EPOS, LITMUS); 18 european countries. https://pubmed.ncbi.nlm.nih.gov/33045403/

You may qualify if:

• Previous Informed consent for cohort studies
• \> 18 years of age
• Diagnosis of SLD (MASLD, MetALD, ALD)

You may not qualify if:

• No consent for previous cohort studies
• \< 18 years of age
• No Diagnosis of SLD (MASLD, MetALD, ALD)

Sponsors & Collaborators

• Universität des Saarlandes: lead
• 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

Study Sites (4)

Hôpital de la Pitié Salpêtrière

Paris, 75013, France

Location

University Medical Center Saarland, Department of Internal Medicine II

Homburg, Saarland, 66421, Germany

Location

Division of Gastroenterology, Department of Medical Sciences, University of Turin

Turin, Italy

Location

Translational & Clinical Research Institute Faculty of Medical Sciences

Newcastle upon Tyne, NE2 4HH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Jörn M. Schattenberg, MD

CONTACT

+49684116; gastroenterologie@uks.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1); FR (1); DE (1); GB (1)