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| Name | Class |
|---|---|
| University Hospital St. Polten | OTHER |
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This study looks to gather data on hepatomiR, a CE-certified test already intended for gauging liver-related outcomes, in order to define a cut-off regarding specific decompensation events (ascites, variceal hemorrhage, hepatic encephalopathy) in chronic liver disease (CLD). Based on these data, it is aimed to advance the current understanding of factors driving decompensation, with potential repercussions for future risk management and therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cACLD | Patients with compensated advanced chronic liver disease (cACLD) regardless of etiology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatomiR | Diagnostic Test | hepatomiR is a CE-certified test intended for gauging liver-related outcomes. It quantifies the levels of hsa-miR-122-5p, hsa-miR-192-5p, and hsa-miR-151a-5p in human plasma samples. A proprietary algorithm is then used to compute a liver function score (hepatomiR p-score). |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any hepatic decompensation event (per patient) | Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number and type of individual decompensation events (per patient) | 12 months | |
| Number of hospital admissions (per patient) | 12 months | |
| Number of acute on chronic liver failure events (per patient) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is made up of patients with compensated advanced chronic liver disease (cACLD) regardless of etiology; cACLD will be defined as per the Baveno VII consensus (LSM values: ≥ 10 kPa ACLD, less than 10 kPa non-ACLD).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukas Erhart, Mag. Dr. | Contact | 00432742900412311 | lukas.erhart@stpoelten.lknoe.at |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Maieron, PD Dr. | Karl Landsteiner University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital St. Pölten | Recruiting | Sankt Pölten | Lower Austria | 3100 | Austria |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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|
EF-CLIF (European Association for the Study of the Liver - Chronic Liver Failure) definition, CLIF-C (chronic liver failure score) ACLF (acute on chronic liver failure) grading |
| 12 months |
| Number of ICU (intensive care unit) admissions (per patient) | 12 months |
| Development of hepatocellular cancer or cholangiocarcinoma (per patient) | 12 months |
| Number of deaths | 12 months |