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NCT07914582
Steatotic Liver Disease in Austria - Prospective Registry With Biobank
Conditions: Steatotic Liver Disease
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 20000
Sponsor: Medical University of Vienna
Location: Medical University of Vienna Vienna State of Vienna
Summary
Steatotic liver disease (SLD) is the most common chronic liver disease and is associated with an increased risk of liver-related complications, cardiovascular disease, and malignancies. However, comprehensive prospective data on the clinical characteristics, disease progression, and management of patients with SLD in Austria remain limited.
The SLD-AT study is a multicenter, prospective, observational registry with an associated biobank aiming to characterize patients with suspected or confirmed SLD in Austria. The registry will collect longitudinal clinical, laboratory, imaging, and treatment-related data to investigate disease progression, clinical outcomes, and the prognostic value of non-invasive tests and biomarkers.
The study aims to enroll approximately 20,000 participants over a planned duration of 15 years.
Eligibility Criteria
Inclusion Criteria:
* 1\. Age 18-100 years.
* 2\. Suspected steatotic liver disease (SLD), defined by at least one of the following criteria:
* Suspected SLD based on previous medical findings.
* Evidence of hepatic steatosis assessed by, Controlled attenuation parameter (CAP), Ultrasound, Magnetic resonance imaging (MRI), or Liver histology
* Suspected advanced liver fibrosis assessed by Vibration-controlled transient elastography (VCTE; ≥8 kPa), Ultrasound, Magnetic resonance elastography (MRE), or Liver histology
* Elevated liver enzymes (AST, ALT, and/or GGT) within 6 months prior to enrollment.
* 3\. Written informed consent to participate in the registry.
Exclusion Criteria:
* Withdrawal of written informed consent.
* Diagnosis of any of the following active chronic liver diseases:
* Chronic hepatitis B
* Chronic hepatitis C
* Autoimmune or cholestatic liver disease
* Genetic liver disease
* Current diagnosis of alcohol-associated hepatitis.
* Current decompensated liver cirrhosis.
Source: ClinicalTrials.gov (NCT07914582). StuddyBuddy aggregates publicly available trial information.