VICIS - Vienna Cirrhosis Study

NCT03267615 | Recruiting

• 1 other identifier: VICIS
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial - including an optional participation in a biobank. Clinical parameters and laboratory parameters will be recorded for all patients and patients will undergo a regular follow-up schedule with clinical visits at the Vienna General Hospital. This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, liver biopsies and stool collected from the study participants.

Conditions

Liver Cirrhosis; Portal Hypertension; Ascites; Variceal Hemorrhage; Hepatic Encephalopathy

Keywords

Liver Cirrhosis; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• Transplant-free survival

  Time from inclusion to death or liver transplantation

  01/FEB/2017 - 31/DECEMBER/2027

Secondary Outcomes (1)

• Decompensation-free survival

  01/FEB/2017 - 31/DECEMBER/2027

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with advanced chronic liver disease diagnosed and/or treated at the Medical University of Vienna will be screened for inclusion/exclusion criteria.

You may qualify if:

• Age \>18 years and \<100 years
• Diagnosis of advanced chronic liver disease (by liver stiffness ≥10kPa, HVPG\>5mmHg or Histology F3/F4)
• Written informed consent

You may not qualify if:

• Withdrawal of written informed consent

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (22)

• Kramer G, Simbrunner B, Jachs M, Balcar L, Hofer BS, Dominik N, Hartl L, Schwarz M, Semmler G, Sebesta C, Thone P, Geisselbrecht S, Maasoumy B, Alvarez E, McCoy MS, Petrenko O, Reinis J, Schwabl P, Stattermayer AF, Trauner M, Mandorfer M, Reiberger T. Blood-based Vienna 3P/5P risk models accurately predict first hepatic decompensation in compensated advanced chronic liver disease. JHEP Rep. 2025 Oct 17;8(2):101642. doi: 10.1016/j.jhepr.2025.101642. eCollection 2026 Feb.

  PMID: 41551411 DERIVED

• Jachs M, Carvalho T, Simbrunner B, Semmler G, Hartl L, Balcar L, Hofer BS, Thone P, Dominik N, Kramer G, Sebesta C, Schwarz M, Bauer D, Stattermayer AF, Pinter M, Trauner M, Reiberger T, Mandorfer M. Indocyanine Green Clearance Correlates With Biomarkers Reflecting Key Disease-Driving Mechanisms in Advanced Chronic Liver Disease and Predicts Acute-on-Chronic Liver Failure and Death. Aliment Pharmacol Ther. 2025 Nov 5. doi: 10.1111/apt.70447. Online ahead of print.

  PMID: 41194563 DERIVED

• Simbrunner B, Villesen IF, Semmler G, Balcar L, Kramer G, Almeida Calvao J, Hofer BS, Jachs M, Hartl L, Maurer J, Scheiner B, Zinober K, Marculescu R, Trauner M, Karsdal M, Reiberger T, Mandorfer M, Leeming DJ. Biomarkers of Extracellular Matrix Remodelling Are Linked to Severity and Outcome of Advanced Chronic Liver Disease. Aliment Pharmacol Ther. 2025 Oct 12. doi: 10.1111/apt.70407. Online ahead of print.

  PMID: 41077886 DERIVED

• Dominik N, Simbrunner B, Scheiner B, Schwarz M, Hartl L, Jachs M, Balcar L, Semmler G, Kramer G, Sebesta C, Trauner M, Pinter M, Mandorfer M, Reiberger T, Hofer BS. Smoking Aggravates Inflammation, Fibrogenesis, Angiogenesis and Cancer Risk in Patients With Cirrhosis. Liver Int. 2025 Oct;45(10):e70314. doi: 10.1111/liv.70314.

  PMID: 40899194 DERIVED

• Hofer BS, Simbrunner B, Konigshofer P, Brusilovskaya K, Petrenko O, Taru V, Sorz-Nechay T, Zinober K, Regnat K, Semmler G, Lackner C, Trauner M, Mandorfer M, Schwabl P, Reiberger T. Inflammation remains a dynamic component of portal hypertension in regressive alcohol-related cirrhosis. United European Gastroenterol J. 2025 Apr;13(3):317-329. doi: 10.1002/ueg2.12643. Epub 2024 Dec 21.

  PMID: 39708052 DERIVED

• Simbrunner B, Hofer BS, Schwabl P, Zinober K, Petrenko O, Fuchs C, Semmler G, Marculescu R, Mandorfer M, Datz C, Trauner M, Reiberger T. FXR-FGF19 signaling in the gut-liver axis is dysregulated in patients with cirrhosis and correlates with impaired intestinal defence. Hepatol Int. 2024 Jun;18(3):929-942. doi: 10.1007/s12072-023-10636-4. Epub 2024 Feb 8.

  PMID: 38332428 DERIVED

• Hartl L, Simbrunner B, Jachs M, Wolf P, Bauer DJM, Scheiner B, Balcar L, Semmler G, Schwarz M, Marculescu R, Dannenberg V, Trauner M, Mandorfer M, Reiberger T. Lower free triiodothyronine (fT3) levels in cirrhosis are linked to systemic inflammation, higher risk of acute-on-chronic liver failure, and mortality. JHEP Rep. 2023 Nov 1;6(1):100954. doi: 10.1016/j.jhepr.2023.100954. eCollection 2024 Jan.

  PMID: 38125301 DERIVED

• Simbrunner B, Villesen IF, Scheiner B, Paternostro R, Schwabl P, Stattermayer AF, Marculescu R, Pinter M, Quehenberger P, Trauner M, Karsdal M, Lisman T, Reiberger T, Leeming DJ, Mandorfer M. Von Willebrand factor processing in patients with advanced chronic liver disease and its relation to portal hypertension and clinical outcome. Hepatol Int. 2023 Dec;17(6):1532-1544. doi: 10.1007/s12072-023-10577-y. Epub 2023 Aug 21.

  PMID: 37605068 DERIVED

• Hartl L, Simbrunner B, Jachs M, Wolf P, Bauer DJM, Scheiner B, Balcar L, Semmler G, Schwarz M, Marculescu R, Trauner M, Mandorfer M, Reiberger T. An impaired pituitary-adrenal signalling axis in stable cirrhosis is linked to worse prognosis. JHEP Rep. 2023 May 11;5(8):100789. doi: 10.1016/j.jhepr.2023.100789. eCollection 2023 Aug.

  PMID: 37484210 DERIVED

• Hofer BS, Simbrunner B, Hartl L, Jachs M, Balcar L, Paternostro R, Schwabl P, Semmler G, Scheiner B, Trauner M, Mandorfer M, Reiberger T. Hepatic recompensation according to Baveno VII criteria is linked to a significant survival benefit in decompensated alcohol-related cirrhosis. Liver Int. 2023 Oct;43(10):2220-2231. doi: 10.1111/liv.15676. Epub 2023 Jul 20.

  PMID: 37469291 DERIVED

• Simbrunner B, Hartl L, Jachs M, Bauer DJM, Scheiner B, Hofer BS, Stattermayer AF, Marculescu R, Trauner M, Mandorfer M, Reiberger T. Dysregulated biomarkers of innate and adaptive immunity predict infections and disease progression in cirrhosis. JHEP Rep. 2023 Feb 24;5(5):100712. doi: 10.1016/j.jhepr.2023.100712. eCollection 2023 May.

  PMID: 37035457 DERIVED

• Simbrunner B, Caparros E, Neuwirth T, Schwabl P, Konigshofer P, Bauer D, Marculescu R, Trauner M, Scheiner B, Stary G, Mandorfer M, Reiberger T, Frances R. Bacterial translocation occurs early in cirrhosis and triggers a selective inflammatory response. Hepatol Int. 2023 Aug;17(4):1045-1056. doi: 10.1007/s12072-023-10496-y. Epub 2023 Mar 7.

  PMID: 36881247 DERIVED

• Balcar L, Krawanja J, Scheiner B, Paternostro R, Simbrunner B, Semmler G, Jachs M, Hartl L, Stattermayer AF, Schwabl P, Pinter M, Szekeres T, Trauner M, Reiberger T, Mandorfer M. Impact of ammonia levels on outcome in clinically stable outpatients with advanced chronic liver disease. JHEP Rep. 2023 Jan 23;5(4):100682. doi: 10.1016/j.jhepr.2023.100682. eCollection 2023 Apr.

  PMID: 36873421 DERIVED

• Hofer BS, Simbrunner B, Hartl L, Jachs M, Bauer DJM, Balcar L, Paternostro R, Schwabl P, Semmler G, Scheiner B, Staettermayer AF, Trauner M, Mandorfer M, Reiberger T. Alcohol Abstinence Improves Prognosis Across All Stages of Portal Hypertension in Alcohol-Related Cirrhosis. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2308-2317.e7. doi: 10.1016/j.cgh.2022.11.033. Epub 2022 Dec 5.

  PMID: 36481475 DERIVED

• Reinis J, Petrenko O, Simbrunner B, Hofer BS, Schepis F, Scoppettuolo M, Saltini D, Indulti F, Guasconi T, Albillos A, Tellez L, Villanueva C, Brujats A, Garcia-Pagan JC, Perez-Campuzano V, Hernandez-Gea V, Rautou PE, Moga L, Vanwolleghem T, Kwanten WJ, Francque S, Trebicka J, Gu W, Ferstl PG, Gluud LL, Bendtsen F, Moller S, Kubicek S, Mandorfer M, Reiberger T. Assessment of portal hypertension severity using machine learning models in patients with compensated cirrhosis. J Hepatol. 2023 Feb;78(2):390-400. doi: 10.1016/j.jhep.2022.09.012. Epub 2022 Sep 22.

  PMID: 36152767 DERIVED

• Simbrunner B, Villesen IF, Konigshofer P, Scheiner B, Bauer D, Paternostro R, Schwabl P, Timelthaler G, Ramazanova D, Woran K, Stift J, Eigenbauer E, Stattermayer AF, Marculescu R, Pinter M, Moller S, Trauner M, Karsdal M, Leeming DJ, Reiberger T, Mandorfer M. Systemic inflammation is linked to liver fibrogenesis in patients with advanced chronic liver disease. Liver Int. 2022 Nov;42(11):2501-2512. doi: 10.1111/liv.15365. Epub 2022 Aug 25.

  PMID: 35822301 DERIVED

• Hofer BS, Simbrunner B, Bauer DJM, Paternostro R, Schwabl P, Scheiner B, Semmler G, Hartl L, Jachs M, Datterl B, Staettermayer AF, Trauner M, Mandorfer M, Reiberger T. Acute hemodynamic response to propranolol predicts bleeding and nonbleeding decompensation in patients with cirrhosis. Hepatol Commun. 2022 Sep;6(9):2569-2580. doi: 10.1002/hep4.2021. Epub 2022 Jul 8.

  PMID: 35808889 DERIVED

• Scheiner B, Balcar L, Nussbaumer RJ, Weinzierl J, Paternostro R, Simbrunner B, Hartl L, Jachs M, Bauer D, Stattermayer AF, Semmler G, Pinter M, Ay C, Quehenberger P, Trauner M, Reiberger T, Lisman T, Mandorfer M. Factor VIII/protein C ratio independently predicts liver-related events but does not indicate a hypercoagulable state in ACLD. J Hepatol. 2022 May;76(5):1090-1099. doi: 10.1016/j.jhep.2021.12.038. Epub 2022 Jan 20.

  PMID: 35066090 DERIVED

• Simbrunner B, Semmler G, Stadlmann A, Scheiner B, Schwabl P, Paternostro R, Bucsics T, Bauer D, Eigenbauer E, Pinter M, Stattermayer AF, Quehenberger P, Marculescu R, Trauner M, Mandorfer M, Reiberger T. Vitamin A levels reflect disease severity and portal hypertension in patients with cirrhosis. Hepatol Int. 2020 Dec;14(6):1093-1103. doi: 10.1007/s12072-020-10112-3. Epub 2020 Dec 8.

  PMID: 33289910 DERIVED

• Costa D, Simbrunner B, Jachs M, Hartl L, Bauer D, Paternostro R, Schwabl P, Scheiner B, Stattermayer AF, Pinter M, Trauner M, Mandorfer M, Reiberger T. Systemic inflammation increases across distinct stages of advanced chronic liver disease and correlates with decompensation and mortality. J Hepatol. 2021 Apr;74(4):819-828. doi: 10.1016/j.jhep.2020.10.004. Epub 2020 Oct 16.

  PMID: 33075344 DERIVED

• Raeven P, Baron-Stefaniak J, Simbrunner B, Stadlmann A, Schwabl P, Scheiner B, Schaden E, Eigenbauer E, Quehenberger P, Mandorfer M, Baron DM, Reiberger T. Thromboelastometry in patients with advanced chronic liver disease stratified by severity of portal hypertension. Hepatol Int. 2020 Dec;14(6):1083-1092. doi: 10.1007/s12072-020-10093-3. Epub 2020 Sep 30.

  PMID: 33000389 DERIVED

• Simbrunner B, Marculescu R, Scheiner B, Schwabl P, Bucsics T, Stadlmann A, Bauer DJM, Paternostro R, Eigenbauer E, Pinter M, Stattermayer AF, Trauner M, Mandorfer M, Reiberger T. Non-invasive detection of portal hypertension by enhanced liver fibrosis score in patients with different aetiologies of advanced chronic liver disease. Liver Int. 2020 Jul;40(7):1713-1724. doi: 10.1111/liv.14498. Epub 2020 May 18.

  PMID: 32358998 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, Serum, Urine, Stool, GI mucosa biopsies, ascitic fluid, liver tissue

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Ascites; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Thomas Reiberger, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Reiberger, M.D.

CONTACT

+43140400; thomas.reiberger@meduniwien.ac.at

Mattias Mandorer, M.D.

CONTACT

+43140400; mattias.mandorfer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Priv-Doz. Dr.

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: February 1, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)