Clinical trial NCT04721665: German SLD-Registry (Deutsches SLD-Register)
Official title: German SLD-Registry Characterization of Patients with Steatotic Liver Disease (SLD) in Germany - Phase 1 (observation of the Natural Course)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Steatotic Liver Disease
Lead sponsor: Leberstiftungs-GmbH Deutschland
Sponsor class: INDUSTRY
First posted: 2021-01-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The number of patients to be enrolled with SLD is limited to 10,000.

Brief summary: Characterization of patients with steatotic liver disease (SLD)

The German SLD-Registry (Deutsches SLD-Register) a project of the German Liver Foundation (Deutsche Leberstiftung), managed by Leberstiftungs-GmbH Deutschland.

The German NAFLD-Registry is financially supported by: Advanz Pharma Specialty Medicine Deutschland GmbH und Gilead Sciences GmbH (Grant to German Livber Foundation) sowie Novo Nordisk Pharma GmbH (directly via Leberstiftungs-GmbH).

Detailed description: The following data can be documented:

* physical examination and vital parameters (e.g. age, weight)
* comorbidities (e.g. diabetes mellitus, cardiovascular disease)
* comedication (treatment of comorbidities related to SLD)
* laboratory values (e.g. liver function tests, creatinine)
* genetic variants (e.g. PNPLA3)
* liver diagnostics (e.g. histological findings, sonographic findings)
* lifestyle (alcohol consumption, physical activity)
* health related quality of life (SF-36 questionnaire)

Eligibility criteria: Inclusion Criteria:

* diagnosed SLD based on the following criteria:

  1. typical finding of hepatic steatosis (abdominal ultrasound and/or pathological CAP value (latter is optional)
  2. Evaluation of SLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/or transient elastography
  3. Evaluation of metabolic syndrome
* credible assessment of alcohol consumption
* written informed consent

Exclusion Criteria:

* patients with other hepatologic diseases (chronically viral, metabolic, autoimmune origin
* patients receiving hepatotoxic medications over a longer period (e.g. methotrexate, amiodarone, longterm NSAR intake)
* malignant disease with a life expectancy \<12 months
* participation in clinical interventional/pivotal studies
* inability to provide written informed consent

Primary outcomes:
measure: Progression of liver fibrosis
timeFrame: through study completion, an average of 1 year
measure: Activity of metabolic dysfunction-associated steatohepatitis (MASH)
timeFrame: through study completion, an average of 1 year
measure: Cardiovascular events
timeFrame: through study completion, an average of 1 year
measure: Tumor diseases
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Infektiologisches Zentrum Steglitz
city: Berlin
country: Germany
facility: Leber- und Studienzentrum Checkpoint
city: Berlin
country: Germany
facility: MVZ für Gastroenterologie am Bayerischen Platz
city: Berlin
country: Germany
facility: Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer
city: Dornstadt
country: Germany
facility: Praxis Ludwig und Dikopoulos
city: Hamburg
country: Germany
facility: Fachinternistische Schwerpunktpraxis
city: Herne
country: Germany
facility: Gastroenterologische Studiengesellschaft Herne
city: Kiel
country: Germany
facility: Leberstudienzentrum Kiel
city: Köln
country: Germany
facility: MVZ Viszeralmedizin GmbH
city: Leipzig
country: Germany
facility: Eugastro GmbH
city: Leverkusen
country: Germany
facility: MVZ Dres. Eisenbach,Simon, Schwarz GbR
city: Magdeburg
country: Germany
facility: Praxis Dr. med. Kerstin Stein
city: Münster
country: Germany
facility: CIM GmbH
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital Medizinische Klinik II
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Stefan Zeuzem, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: