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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.
Patients with advanced chronic liver disease (ACLD) as evident by HVPG>5mmHg or liver biopsy showing F3/F4 fibrosis or as suggested by liver stiffness measurement (LSM) ≥10kPa can be included in the VICIS study. Most patients will be recruited on the day of HVPG measurement performed for screening of clinically significant portal hypertension (CSPH) or on the day of upper GI endoscopy for screening for the presence of varices. Next to the detailed characterization of patients by epidemiologic, clinical and laboratory parameters, the degree of portal hypertension will be assessed by HVPG, liver (LSM) and spleen (SSM) stiffness will be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic collaterals, PVT and liver lesions will be assessed by ultrasound and optionally cross-sectional imaging.
In addition, patients will be asked to (optionally) participate in biobank sampling including serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, stool, liver biopsies and stool. All patients recruited in the VICIS study will be prospectively followed every 3 months (decompenated ACLD) or every 6 months (compensated ACLD) patients with clinical visits at the Cirrhosis Outpatient Clinic at the Vienna General Hospital. These assessments include a detailed assessment of risk factors (such as a structured interview of alcohol consumption), the recording of decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening for PVT and HCC, recording of medications and other clinically-relevant information.
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| Measure | Description | Time Frame |
|---|---|---|
| Transplant-free survival | Time from inclusion to death or liver transplantation | 01/FEB/2017 - 31/DECEMBER/2027 |
| Measure | Description | Time Frame |
|---|---|---|
| Decompensation-free survival | Time from inclusion to decompensation, death or liver transplantation | 01/FEB/2017 - 31/DECEMBER/2027 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with advanced chronic liver disease diagnosed and/or treated at the Medical University of Vienna will be screened for inclusion/exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Reiberger, M.D. | Contact | +43140400 | 65890 | thomas.reiberger@meduniwien.ac.at |
| Mattias Mandorer, M.D. | Contact | +43140400 | 47410 | mattias.mandorfer@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Reiberger, M.D. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42174757 | Derived | Pfisterer N, Lie-Ungurean I, Maurer J, Bauer D, Hengstschlaeger H, Noe A, Balcar L, Scheiner B, Schwabl P, Marculescu R, Woran K, Mozayani B, Madl C, Trauner M, Mandorfer M, Reiberger T, Simbrunner B. The Link of Portal-Hypertensive Gastropathy to Anaemia, Systemic Inflammation and Disease Progression in Cirrhosis. Liver Int. 2026 Jun;46(6):e70700. doi: 10.1111/liv.70700. | |
| 41551411 |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| D001201 | Ascites |
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Plasma, Serum, Urine, Stool, GI mucosa biopsies, ascitic fluid, liver tissue
| Derived |
| 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. |
| 41194563 | 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. 2026 Mar;63(6):874-884. doi: 10.1111/apt.70447. Epub 2025 Nov 5. |
| 41077886 | 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. 2026 Mar;63(5):648-661. doi: 10.1111/apt.70407. Epub 2025 Oct 12. |
| 40899194 | 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. |
| 40467020 | Derived | Hartl L, Hintersteininger M, Simbrunner B, Jachs M, Hofer BS, Bauer DJM, Dominik N, Schwarz M, Balcar L, Kramer G, Kerbert AJC, Coenraad MJ, Thevenot T, Moreau R, Trebicka J, Claria J, Marculescu R, Trauner M, Mandorfer M, Reiberger T. The Vasopressin Biomarker Copeptin Is Linked to Systemic Inflammation and Refines Prognostication in Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2026 Jan;24(1):131-140. doi: 10.1016/j.cgh.2025.04.030. Epub 2025 Jun 2. |
| 39708052 | 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. |
| 38332428 | 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. |
| 38125301 | 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. |
| 37605068 | 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. |
| 37484210 | 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. |
| 37469291 | 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. |
| 37035457 | 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. |
| 36881247 | 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. |
| 36873421 | 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. |
| 36481475 | 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. |
| 36152767 | 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. |
| 35822301 | 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. |
| 35808889 | 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. |
| 35066090 | 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. |
| 33289910 | 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. |
| 33075344 | 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. |
| 33000389 | 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. |
| 32358998 | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |