NCT07727070Active, not recruiting
Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
A Prospective Observational Multicenter Study of the Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 26 Jun 2026
- Start date
- 5 Dec 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Fadoi Foundation, Italy
- Diseases
- High blood pressure
- NCT number
- NCT07727070
What you commit to
- Study type: Observational
- Planned participants: 400
- From 5 Dec 2025 to the primary completion date, Dec 2026
- 41 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient enrolled in other non-observational clinical trials
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Dei Castelli Coordinator of this site? Confirm its status | Ariccia | Italy | Unknown status |
| Ospedale "Luigi Cazzavillan" Coordinator of this site? Confirm its status | Arzignano | Italy | Unknown status |
| Ospedale di Assisi Coordinator of this site? Confirm its status | Assisi | Italy | Unknown status |
| IRCCS Azienda Ospedaliera-Universitaria Policlinico "S. Orsola" Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Ospedale Centrale di Bolzano Coordinator of this site? Confirm its status | Bolzano | Italy | Unknown status |
| Ospedale A. Perrino Coordinator of this site? Confirm its status | Brindisi | Italy | Unknown status |
| Ospedale "Santo Spirito" Coordinator of this site? Confirm its status | Casale Monferrato | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Renato Dulbecco Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Ospedale "Cervesi" Coordinator of this site? Confirm its status | Cattolica | Italy | Unknown status |
| Ospedale Maggiore Coordinator of this site? Confirm its status | Chieri | Italy | Unknown status |
| Ospedale di Cremona Coordinator of this site? Confirm its status | Cremona | Italy | Unknown status |
| Ospedale "San Giovanni di Dio" Coordinator of this site? Confirm its status | Crotone | Italy | Unknown status |
| Ospedale di Dolo Coordinator of this site? Confirm its status | Dolo | Italy | Unknown status |
| Ospedale del Delta Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Ospedale "S. Maria Annunziata" Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Ospedale "Sacro Cuore di Gesù" Coordinator of this site? Confirm its status | Gallipoli | Italy | Unknown status |
| Ospedale Della Misericordia Coordinator of this site? Confirm its status | Grosseto | Italy | Unknown status |
| Ospedale "Sant'Andrea" Coordinator of this site? Confirm its status | Lamezia Terme | Italy | Unknown status |
| Presidio Ospedaliero "San Salvatore" Coordinator of this site? Confirm its status | L’Aquila | Italy | Unknown status |
| Ospedale Civile di Legnano Coordinator of this site? Confirm its status | Legnano | Italy | Unknown status |
| P.O. di Livorno Coordinator of this site? Confirm its status | Livorno | Italy | Unknown status |
| Ospedale Umberto I di Lugo Coordinator of this site? Confirm its status | Lugo | Italy | Unknown status |
| Azienda Ospedaliera Carlo Poma Coordinator of this site? Confirm its status | Mantua | Italy | Unknown status |
| Ospedale Fatebenefratelli e Oftalmico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedali Riuniti Padova Sud Coordinator of this site? Confirm its status | Monselice | Italy | Unknown status |
| AORN A. Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedale "Vincenzo Monaldi" - AOS dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedale "Umberto I°" di Nocera Coordinator of this site? Confirm its status | Nocera Inferiore | Italy | Unknown status |
| AOU "Maggiore della Carità" Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Ospedale "Buccheri-La Ferla" Fatebenefratelli Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Ospedale Di Camerino Coordinator of this site? Confirm its status | Province of Macerata | Italy | Unknown status |
| Ospedale Santa Maria delle Croci Coordinator of this site? Confirm its status | Ravenna | Italy | Unknown status |
| Isola Tiberina Gemelli-Isola Hospital, Rome Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale "S. Maria della Misericordia" Coordinator of this site? Confirm its status | Rovigo | Italy | Unknown status |
| Ospedale "Girolamo Fracastoro" Coordinator of this site? Confirm its status | San Bonifacio | Italy | Unknown status |
| P.O. Ss. Annunziata Coordinator of this site? Confirm its status | Sassari | Italy | Unknown status |
| Ospedale San Paolo Coordinator of this site? Confirm its status | Savona | Italy | Unknown status |
| Ospedale "Umberto I°" di Siracusa Coordinator of this site? Confirm its status | Syracuse | Italy | Unknown status |
| Ospedale Civile "Giuseppe Mazzini" Coordinator of this site? Confirm its status | Teramo | Italy | Unknown status |
| Ospedale di Circolo di Varese Coordinator of this site? Confirm its status | Varese | Italy | Unknown status |
| Ospedale Civile di Voghera Coordinator of this site? Confirm its status | Voghera | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.