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

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 Overview

• Status: Not yet recruiting
• Conditions: ALD - Alcoholic Liver Disease; Steatotic Liver Disease; Steatotic Liver Disease of Mixed Origin (MetALD); MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

• Study Type: Observational
• Enrollment (Estimated): 30000

Contacts and Locations

• Study Contact: Name: Jörn M. Schattenberg, MD; Phone Number: 15027 +49684116; Email: gastroenterologie@uks.eu

Study Locations

• France
  • Paris, France, 75013
    • Hopital de La Pitie Salpetriere
    • Contact: Scientific Affaires Officer, PhD, MPH; Phone Number: 0033; Email: j.medvedovic@ihuican.org
• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • University Medical Center Saarland, Department of Internal Medicine II
• Italy
  • Turin, Italy
    • Division of Gastroenterology, Department of Medical Sciences, University of Turin
    • Contact: Division of Gastroenterology, Department of Medical Sciences; Phone Number: 0039 11 6333272; Email: elisabetta.bugianesi@unito.it
• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE2 4HH
    • Translational & Clinical Research Institute Faculty of Medical Sciences
    • Contact: Kristy Wonders; Phone Number: +44; Email: SLD.Registry@newcastle.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

European SLD register (historically EPOS, LITMUS); 18 european countries.

https://pubmed.ncbi.nlm.nih.gov/33045403/

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Universität des Saarlandes
• Collaborators: Assistance Publique - Hôpitaux de Paris; Odense University Hospital; Hospital Clinic of Barcelona; Newcastle University; University of Turin, Italy; Barcelona Institute for Global Health; Universitatsmedizin Mainz - 1. Medizinische Klinik

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Liver; Metabolism; ALD; SLD; MASLD; MASH; MetALD; NITs
• Additional Relevant MeSH Terms: Digestive System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcohol-Induced Disorders; Liver Diseases; Fatty Liver; Liver Diseases, Alcoholic
• Other Study ID Numbers: LOVE study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No