Actively Recruiting
Assessment of a hepatomiR Cut-off for Predicting Liver Decompensation Events in Advanced Chronic Liver Disease
Led by Karl Landsteiner University of Health Sciences · Updated on 2025-09-09
156
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karl Landsteiner University of Health Sciences
Lead Sponsor
U
University Hospital St. Polten
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are gathering data on hepatomiR, a CE-certified diagnostic test designed to assess liver-related outcomes. The study focuses on patients with compensated advanced chronic liver disease (cACLD) of any cause. Its purpose is to establish a cut-off value for hepatomiR that predicts specific liver decompensation events such as ascites, variceal hemorrhage, and hepatic encephalopathy. This aims to improve understanding of factors causing decompensation and support future risk management and treatment approaches. The study involves patients who undergo the hepatomiR test, which measures levels of specific microRNAs in plasma samples to calculate a liver function score. Participants are outpatients at the Clinical Department of Internal Medicine II, University Hospital St. Pölten. The study will observe outcomes over a 12-month period without administering additional treatments. During the study, researchers will monitor the occurrence of hepatic decompensation events, hospital and intensive care admissions, development of liver cancers, and deaths. Data collection includes clinical assessments and monitoring liver disease progression. The total participation covers at least 12 months of follow-up to evaluate these outcomes and understand the predictive value of hepatomiR.
CONDITIONS
Brief Title
hepatomiR cACLD Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chronic liver disease lasting more than 6 months
- Liver stiffness measurement (LSM) of 10 kPa or higher
- Outpatient at the Clinical Department of Internal Medicine II, University Hospital St. Pölten
- Signed patient consent form
You will not qualify if you...
- Pregnancy
- Primary liver cancer (hepatocellular carcinoma or cholangiocarcinoma) with portal invasion or spread beyond the liver
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo blood tests to measure hepatomiR levels and compute a liver function score using a proprietary algorithm.
1 visit (in-person)
Duration - 12 months
Participants are observed over 12 months to monitor for any hepatic decompensation events, hospital admissions, acute on chronic liver failure events, ICU admissions, development of liver cancer, or death.
Periodic visits as part of routine outpatient care
Trial Site Locations
Total: 1 location
1
University Hospital St. Pölten
Sankt Pölten, Lower Austria, Austria, 3100
Actively Recruiting
Research Team
L
Lukas Erhart, Mag. Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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