ClinicalTrials.gg
RecruitingNCT07914582SLD-ATUpdated Nov 3, 2026

Steatotic Liver Disease in Austria - Prospective Registry With Biobank

An observational study in Steatotic Liver Disease, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Medical University of Vienna · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

SLD-AT is a multicenter, prospective, observational registry designed to systematically investigate the epidemiology, clinical characteristics, risk factors, management, and long-term outcomes of patients with suspected or confirmed steatotic liver disease (SLD) in Austria.

Adult patients undergoing routine clinical evaluation at participating centers will be invited to participate. Clinical management will follow standard medical practice, without study-mandated therapeutic interventions.

Demographic, anthropometric, clinical, laboratory, and imaging data, including non-invasive assessments of liver fibrosis and steatosis, will be collected at baseline and during follow-up. Follow-up assessments will generally take place every 6-12 months, with longer intervals where clinically appropriate. Liver-related complications, cardiovascular events, malignancies, and mortality will be documented.

An associated biobank will collect and store biological samples, including blood and, where available, urine, stool, and residual liver tissue, for future biomarker research.

The registry aims to improve the understanding of the natural history of SLD, identify predictors of disease progression and clinical outcomes, and evaluate non-invasive diagnostic and prognostic tools in a real-world clinical setting. Approximately 20,000 patients are expected to be enrolled over a planned study duration of 15 years.

02

Conditions studied

  • Steatotic Liver Disease

Keywords

  • MASLD
  • MetALD
  • ALD
  • Steatotic liver disease
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population comprises adult patients (18-100 years) with suspected or confirmed steatotic liver disease (SLD) undergoing routine clinical evaluation at participating healthcare centers in Austria. Patients will be recruited from outpatient clinics and inpatient settings. Eligible participants will be enrolled prospectively following written informed consent and followed longitudinally according to clinical needs.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (, ALT, and/or GGT) within 6 months prior to enrollment.
  • 3. Written to participate in the registry.

Exclusion criteria

Exclusion Criteria:

  • Withdrawal of written .
  • Diagnosis of any of the following active chronic liver diseases:
  • Chronic
  • Chronic
  • or cholestatic liver disease
  • Genetic liver disease
  • Current diagnosis of alcohol-associated hepatitis.
  • Current decompensated liver cirrhosis.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Number of participants developing compensated advanced chronic liver disease (cACLD), as assessed by liver stiffness measurement using vibration-controlled transient elastography (VCTE) >=10 kPa

    The number and proportion of participants without cACLD at baseline who develop cACLD during longitudinal follow-up will be assessed using liver stiffness measurement (LSM, kPa) by vibration-controlled transient elastography (VCTE) with a cut-off \>=10 kPa. Disease progression will be characterized through repeated non-invasive assessments performed as part of routine clinical care. Analyses will primarily be descriptive and may include incidence rates and time-to-event analyses.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual patient data can be shared upon reasonable request and after fulfilling all data protection requirments from the EU.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2025 (actual). Primary completion is estimated for Dec 2040, 185 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Nov 3, 2026
StartActual
Jul 1, 2025
Primary completionEst.
Dec 31, 2040
CompletionEst.
Dec 31, 2040
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914582
Responsible party
Georg Semmler (MD PhD, Medical University of Vienna) — Principal investigator
First posted
Nov 3, 2026
Start date
Jul 1, 2025
Primary completion
Dec 31, 2040 (estimated)
Completion
Dec 31, 2040 (estimated)
Last update
Nov 3, 2026

Study contacts

Georg Semmler, MD PhD
Contact
sld@meduniwien.ac.at
+4314040047410

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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