Steatotic Liver DiseaseSLD-ATNCT07914582
Steatotic Liver Disease in Austria - Prospective Registry With Biobank
An observational study of Steatotic Liver Disease, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Steatotic Liver Disease
- How many people
- 20,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2025to 31 Dec 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Georg Semmler, MD PhD, +4314040047410, georg.semmler@meduniwien.ac.at
About this study
Official title: Steatotic Liver Disease in Austria - Prospective Registry With Biobank (SLD-AT)
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.
- Conditions
- Steatotic Liver Disease
- Keywords
- MASLD, MetALD, ALD, Steatotic liver disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Semmler, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914582
- Sponsor's protocol ID
- 1055/2025
- Acronym
- SLD-AT
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data can be shared upon reasonable request and after fulfilling all data protection requirments from the EU.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steatotic Liver Disease in Austria - Prospective Registry With Biobank (SLD-AT)
- ClinicalTrials.gov ID
- NCT07914582
- Acronym / sponsor ID
- SLD-AT / 1055/2025
- Conditions
- Steatotic Liver Disease
- Keywords
- MASLD, MetALD, ALD, Steatotic liver disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants developing compensated advanced chronic liver disease (cACLD), as assessed by liver stiffness measurement using vibration-controlled transient elastography (VCTE) >=10 kPa
Time frame: 10 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual patient data can be shared upon reasonable request and after fulfilling all data protection requirments from the EU.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatotic Liver Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georg Semmler, MD PhD (+4314040047410, sld@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants developing compensated advanced chronic liver disease (cACLD), as assessed by liver stiffness measurement using vibration-controlled transient elastography (VCTE) >=10 kPa (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.