Clinical Trial

Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine

Study acronym: HEPTAGON
Active, Not Recruiting
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Summary
Patients with decompensated liver cirrhosis are mostly managed in Internal Medicine outpatient clinics and wards; among these patients, overt hepatic encephalopathy represents one of the most frequent causes of emergency hospital admission. Furthermore, hospitalizations for decompensated cirrhosis are expected to increase steadily, given the progressive rise in chronic liver diseases of metabolic and alcohol-related origin. Therefore, the skills of the Internal Medicine physician must increasingly include screening for minimal hepatic encephalopathy, identification and treatment of overt hepatic encephalopathy, and prevention of relapses. In view of the lack of data from prospective studies on the incidence, management, and outcomes of hepatic encephalopathy in patients admitted to Internal Medicine wards in Italy, it is considered important to collect and analyze a large case series in order to identify critical issues in management during hospitalization and at discharge, also with the aim of preventing rehospitalizations. On this basis, Fondazione FADOI has decided to promote the FADOI-HEPTAGON study, a prospective, multicenter, observational study involving approximately 45 Internal Medicine Units across Italy, which will competitively enroll at least 400 consecutive inpatient cases of liver cirrhosis over a one-year period, collecting data on management, treatment, and clinical outcomes during the acute phase and at 3 and 9 months after discharge (follow-up). Among these subjects, patients with hepatic encephalopathy will also be identified in order to assess its incidence.
Trial Details
NCT Number NCT07727070
Lead Sponsor Fadoi Foundation, Italy
Conditions Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis, Liver Stiffness, Hepatic Encephalopathy
Enrollment 400 participants
Start Date 2025-12-05
Primary Completion 2026-12 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-27