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Active, Not Recruiting

NCT Number: NCT07727070

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale dei Castelli, Ariccia, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Signed informed consent
  • Diagnosis of liver cirrhosis according to recognized clinical, laboratory, and imaging criteria and/or evidence of portal hypertension or liver stiffness ≥ 20 kPa.

Exclusion criteria

  • Patient enrolled in other non-observational clinical trials

Treatment and study plan

Primary outcomes

  1. Incidence of hepatic encephalopathy

    Time frame: through study completion, an average of 1 year

    Incidence of both minimal and overt hepatic encephalopathy in patients with liver cirrhosis

Secondary outcomes

  1. Rate of screening for minimal hepatic encephalopathy

    Time frame: through study completion, an average of 1 year

    Rate of screening for minimal hepatic encephalopathy

  2. Rates of in-hospital mortality

    Time frame: from the the discharge untill 9 months

    Rates of in-hospital mortality, 3-month and 9-month mortality

  3. Readmission rates

    Time frame: from the the discharge untill 9 months

    3-month and 9-month readmission rates post-discharge

  4. Rates of counseling

    Time frame: at discharge

    Rates of counseling at discharge

  5. Description of the treatments for overt hepatic encephalopathy

    Time frame: through study completion, an average of 1 year

    Description of the treatments for overt hepatic encephalopathy

Sponsors and collaborators

Lead sponsor

Fadoi Foundation, Italy

Other

Registry information

Official study title

A Prospective Observational Multicenter Study of the Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine

Acronym: HEPTAGON

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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