German SLD-Registry - Characterization of Patients With Steatotic Liver Disease (SLD) in Germany - Phase 1 (Observation of the Natural Course)

Recruiting

Conditions: K76.0
Fatty (change of) liver, not elsewhere classified

Registration Number: DRKS00024354

Lead Sponsor: eberstiftungs-GmbH Deutschland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 10000

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 NAFLD 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Progression of liver fibrosis; time frame: through study completion, an average of 1 year; Fibrosis stage is measured by elastography (elastometry kPa value).<br>- Activity of steatohepatitis (MASH); time frame: through study completion, an average of 1 year; Activity is measured via histology (NAFLD activity score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8.)<br>- Cardiovascular events; time frame: through study completion, an average of 1 year; The onset of the clinical outcome cardiovascular events (yes/no)<br>- Tumor diseases; time frame: through study completion, an average of 1 year; The onset of the clinical outcome tumor diseases (yes/no)

Secondary Outcome Measures

Name	Time	Method
Effectiveness of co-medication (treatment of diseases related to SLD); Identification of clinically relevant Risk markers with respect to disease progression and therapy outcome