Clinical trial NCT06907563: Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)
Official title: Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)
Study type: OBSERVATIONAL
Overall status: 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
Keywords: MASH
SLD
NITs
MASLD
ALD
MetALD
Metabolism
Liver
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: Universitatsmedizin Mainz - 1. Medizinische Klinik
name: Newcastle University
name: Barcelona Institute for Global Health
name: Odense University Hospital
name: Hospital Clinic of Barcelona
name: Assistance Publique - Hôpitaux de Paris
name: University of Turin, Italy
First posted: 2025-04-02
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: European SLD register (historically EPOS, LITMUS); 18 european countries.

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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Major-adverse liver outcomes (MALO)
timeFrame: 5 years follow-up time
measure: All-cause mortality
timeFrame: 5 years follow-up time
Secondary outcomes:
measure: Health-related quality of life (HRQL)
timeFrame: 5 years
measure: Assess prognostic biomarkers and develop a novel tool to integrate them into a digital tool to predict outcomes
timeFrame: 5 years
measure: Major adverse cardiac events (MACE)
timeFrame: 5 years
measure: Development of relevant clinical outcomes
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital de la Pitié Salpêtrière
city: Homburg
country: Germany
facility: University Medical Center Saarland, Department of Internal Medicine II
state: Saarland
city: Turin
country: Italy
facility: Division of Gastroenterology, Department of Medical Sciences, University of Turin
city: Newcastle upon Tyne
country: United Kingdom
facility: Translational & Clinical Research Institute Faculty of Medical Sciences
Study officials:
References: