Chronic Liver Disease, Chronic Liver Disease and Cirrhosis, Portal Hypertension
Conditions
Keywords
hepatomiR, micro-RNA, hepatic decompensation, ACLD
Brief summary
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.
Interventions
DIAGNOSTIC_TESThepatomiR
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).
Sponsors
Karl Landsteiner University of Health Sciences
University Hospital St. Polten
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Chronic liver disease (more than 6 months) * LSM ≥ 10 kPa * Outpatient at the Clinical Department of Internal Medicine II, University Hospital St. Pölten * Signed patient consent form
Exclusion criteria
* Age older than 18 years * Pregnancy * Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of any hepatic decompensation event (per patient) | 12 months | Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 12 months | 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 |
| 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 | — |
Countries
Austria
Contacts
CONTACTLukas Erhart, Mag. Dr.
PRINCIPAL_INVESTIGATORAndreas Maieron, PD Dr.
Karl Landsteiner University of Health Sciences
Outcome results
None listed