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

University of Modena and Reggio Emilia

Status: Unknown

Conditions: Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT03084185

HVPG_HCV

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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