Evaluation of the Role of Plasma Biomarkers in the Development of Decompensation in Patients With Cirrhosis .

Study Overview
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Brief Summary
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This is a single-center and prospective study to identify specific biomarker in order to predict development of decompensation in cirrhotic patients. The duration of the study is 36 months and it provides a cohort of 200 patients.

Detailed Description
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At screening, patient will have taken blood samples and performed hepatic vein pressure gradient. After randomization, patient will be seen at follow up every 3 months to do blood sample and every 12 months to undergo hepatic vein pressure gradient , according to the guidelines. In addition, metabolomics analysis will be performed at screening and every 3 months. The results will be analyzed in relation to emergence of decompensation during follow up period, in order to identify specific metabolomics characteristics that may be able to predict decompensation.

Official Title
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Evaluation of the Role of Plasma Biomarkers for Portal Hypertension Progression and Oxidative Damage in Decompensation of Cirrhotic Patient.

Conditions
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Cirrhosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of liver cirrhosis Aged between 18 and 75 years Obtaining written informed consent Absence of exclusion criteria Exclusion Criteria: Diagnosis of hepatocellular carcinoma Presence of portal vein thrombosis HIV Liver transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis. | Patients will be subject to blood sample periodically and following exams will be made: Chemistry and hematology to define liver function Intestinal Fatty Acid Binding Protein 16S, ribosomal deoxyribonucleic acid Cluster of differentiation 14 Interleukin 6 Asymmetrical dimethylarginine Tissue factor According to current guidelines, patients will be submitted to: Hepatic vein pressure gradient AND combined right heart catheterization Liver elastography | December 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finding of serum metabolomic features of cirrhotic patients. | Analysis will be conducted on sera collected during the screening and every three months. These samples will be examined using liquid chromatography and mass spectrometry in order to obtain the identification of main components and their mass than, the informations will be analyzed by MarkerLynxTM software | December 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decompensation, deficit, metabolomics, portal hypertension