Vascular Liver DiseaseVALIDNCT03541057
Vienna Vascular Liver Disease Study
An observational study of Vascular Liver Disease and Portal Vein Thrombosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this Register Trial is to systematically study the epidemiology, risk factors, liver function as well prognosis of patients with vascular liver diseases. Furthermore, important clinical parameters will be assessed in order to evaluate patients' coagulation status and in order to develop new biomarkers… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vascular Liver Disease, Portal Vein Thrombosis, Budd-Chiari Syndrome
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 12 Dec 2017to Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All consecutive patients with a vascular liver disease (as specified above) presenting at the outpatient department / inpatient ward of the Medical University of Vienna.
Who may be able to join
- Diagnosis of a vascular liver disease by imaging (sonography, CT, MRI), transient elastography or liver histology
- PVT: Portal vein thrombosis
- NCPH: non-cirrhotic Portal Hypertension
- PSVD: porto-sinusoidal vascular disorder
- BCS: Budd-Chiari-Syndrome
- SOS: sinusoidal occlusive disease
Show all 10Show fewer
- HHT: hereditary hemorrhagic teleangiectasia
- CIRCAD: cirrhosis cardiaque
- Age >18 years and <100 years
- Written informed consent obtained
Who cannot join
- withdrawal of written informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Thomas Reiberger, MD, 0043140400 ext. 47410, thomas.reiberger@meduniwien.ac.at
Bernhard Scheiner, MD, 0043140400 ext. 47410, bernhard.scheiner@meduniwien.ac.at
About this study
Official title: Vienna Vascular Liver Disease Study: Characterization of Patients With Vascular Liver Disease - a Registry With Biobank
The aim of this Register Trial is to systematically study the epidemiology, risk factors, liver function as well prognosis of patients with vascular liver diseases. Furthermore, important clinical parameters will be assessed in order to evaluate patients' coagulation status and in order to develop new biomarkers derived from blood, urine, stool or ascites of patients as well as histological samples from the upper / lower GI-tract or the liver in order to better understand the natural history of vascular liver diseases.
Read the detailed description
We will include patients with vascular liver diseases, including
- portal vein thrombosis (PVT)
- Budd-Chiari Syndrome (BCS)
- Heredetary Hemorrhagic Teleangiectasia (HHT, or Osler-Rendu Disease)
- Noncirrhotic-portal hypertension (NCPH) and Porto-sinusoidal vascular disorder
- Cirrhosis cardiaque if the fulfill inclusion/exclusion criteria and provide written informed consent. Participation in the biobank is optional for the patients. In particular, we will study the natural course of the patients in regard to hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), need for intensified treatment (TIPS, ICU, liver transplantation) and survival.
- Conditions
- Vascular Liver Disease, Portal Vein Thrombosis, Budd-Chiari Syndrome, Non-Cirrhotic Portal Hypertension, Rendu Osler Weber, Cardiac Cirrhosis
- Medical subject headings
- Budd-Chiari Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Decompensation
Any first hepatic decompensation: variceal bleeding, new onset of ascites, new onset of hepatic encephalopathy, new onset of jaundice
Measured: Up to 10 years (=Study Period)
Secondary outcomes (2)
Liver-related death
Death from a liver-related cause
Measured: Up to 10 years (=Study Period)
Coagulation status
Coagulation status of the Patient as assessed by advanced coagulation tests (including TEG-ROTEM and TGA)
Measured: Up to 10 years (=Study Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start12 Dec 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular 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
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Reiberger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541057
- Sponsor's protocol ID
- VALID 1928/2017
- Acronym
- VALID
- Status last verified
- Dec 2023
- First submitted
- 6 May 2018
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balcar L, Dominik N, Mozayani B, Semmler G, Halilbasic E, Mandorfer M, Reiberger T, Trauner M, Scheiner B, Stattermayer AF. Elevated Hepatic Copper Content in Porto-Sinusoidal Vascular Disorder (PSVD): Leading Down a Wrong Track. Liver Int. 2025 Feb;45(2):e16175. doi: 10.1111/liv.16175.
PubMed 39807082
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vienna Vascular Liver Disease Study: Characterization of Patients With Vascular Liver Disease - a Registry With Biobank
- ClinicalTrials.gov ID
- NCT03541057
- Acronym / sponsor ID
- VALID / VALID 1928/2017
- Conditions
- Vascular Liver Disease, Portal Vein Thrombosis, Budd-Chiari Syndrome, Non-Cirrhotic Portal Hypertension, Rendu Osler Weber, Cardiac Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 May 2018 (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.
The aim of this Register Trial is to systematically study the epidemiology, risk factors, liver function as well prognosis of patients with vascular liver diseases. Furthermore, important clinical parameters will be assessed in order to evaluate patients' coagulation status and in order to develop new biomarkers derived from blood, urine, stool or ascites of patients as well as histological samples from the upper / lower GI-tract or the liver in order to better understand the natural history of vascular liver diseases.
Detailed description
We will include patients with vascular liver diseases, including
- portal vein thrombosis (PVT)
- Budd-Chiari Syndrome (BCS)
- Heredetary Hemorrhagic Teleangiectasia (HHT, or Osler-Rendu Disease)
- Noncirrhotic-portal hypertension (NCPH) and Porto-sinusoidal vascular disorder
- Cirrhosis cardiaque if the fulfill inclusion/exclusion criteria and provide written informed consent. Participation in the biobank is optional for the patients. In particular, we will study the natural course of the patients in regard to hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), need for intensified treatment (TIPS, ICU, liver transplantation) and survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients with a vascular liver disease (as specified above) presenting at the outpatient department / inpatient ward of the Medical University of Vienna.
Key inclusion criteria (10 listed)
- Diagnosis of a vascular liver disease by imaging (sonography, CT, MRI), transient elastography or liver histology
- PVT: Portal vein thrombosis
- NCPH: non-cirrhotic Portal Hypertension
- PSVD: porto-sinusoidal vascular disorder
- BCS: Budd-Chiari-Syndrome
Key exclusion criteria (1 listed)
- withdrawal of written informed consent
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
Hepatic Decompensation
Time frame: Up to 10 years (=Study Period)
Any first hepatic decompensation: variceal bleeding, new onset of ascites, new onset of hepatic encephalopathy, new onset of jaundice
2 secondary outcomes
Liver-related death
Time frame: Up to 10 years (=Study Period)
Coagulation status
Time frame: Up to 10 years (=Study Period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 39807082Balcar L, Dominik N, Mozayani B, Semmler G, Halilbasic E, Mandorfer M, Reiberger T, Trauner M, Scheiner B, Stattermayer AF. Elevated Hepatic Copper Content in Porto-Sinusoidal Vascular Disorder (PSVD): Leading Down a Wrong Track. Liver Int. 2025 Feb;45(2):e16175. doi: 10.1111/liv.16175.
Related trials for Vascular Liver Disease
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Active, not recruitingPhase 2
Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma
Hepatocellular Cancer, Hepatocellular Carcinoma
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruitingObservational study
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
Obesity & Overweight, Diabetes Mellitus, Type 2
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. This study is not recruiting at the moment.
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 Vascular Liver Disease and Portal Vein Thrombosis, 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 10 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Reiberger, MD (0043140400 ext. 47410, thomas.reiberger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic Decompensation (time frame: Up to 10 years (=Study Period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03541057, which also lists 1 linked publication.
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 Jan 2024.