German SLD-Registry (Deutsches SLD-Register)

Leberstiftungs-GmbH Deutschland1,681 enrolled

Overview

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).

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)

Study Type

OBSERVATIONAL

Enrollment

1,681

Conditions

Steatotic Liver Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Infektiologisches Zentrum Steglitz

Berlin, Germany

Leber- und Studienzentrum Checkpoint

Berlin, Germany

MVZ für Gastroenterologie am Bayerischen Platz

Berlin, Germany

Outcomes

Primary Outcomes

Progression of liver fibrosis

Fibrosis stage is measured by elastography (elastometry kPa value).

Time frame: through study completion, an average of 1 year

Activity of metabolic dysfunction-associated steatohepatitis (MASH)

Activity is measured via histology (NAFLD activity score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8.)

Time frame: through study completion, an average of 1 year

Cardiovascular events

The onset of the clinical outcome cardiovascular events (yes/no)

Time frame: through study completion, an average of 1 year

Tumor diseases

The onset of the clinical outcome tumor diseases (yes/no)

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

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