Cirrhoses, LiverHEPTAGONNCT07727070
Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
An observational study of Cirrhoses, Liver and Portal Hypertension Related to Cirrhosis, run by Fadoi Foundation, Italy at 41 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis, Liver Stiffness
- How many people
- 400 participants
- Where
- 41 sitesItaly
- Study dates
- 5 Dec 2025to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalization in Internal Medicine
Who may be able to join
- 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.
Who cannot join
- Patient enrolled in other non-observational clinical trials
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
Italy41 sites
Ospedale dei Castelli
Ariccia
Ospedale "Luigi Cazzavillan"
Arzignano
Ospedale di Assisi
Assisi
IRCCS Azienda Ospedaliera-Universitaria Policlinico "S. Orsola"
Bologna
Ospedale Centrale di Bolzano
Bolzano
Ospedale "A. Perrino"
Brindisi
Ospedale "Santo Spirito"
Casale Monferrato
Azienda Ospedaliero Universitaria "Renato Dulbecco"
Catanzaro
Ospedale "Cervesi"
Cattolica
Ospedale Maggiore
Chieri
Ospedale di Cremona
Cremona
Ospedale "San Giovanni di Dio"
Crotone
Ospedale di Dolo
Dolo
Ospedale del Delta
Ferrara
Ospedale "S. Maria Annunziata"
Florence
Ospedale "Sacro Cuore di Gesù"
Gallipoli
Ospedale della Misericordia
Grosseto
Presidio Ospedaliero "San Salvatore"
L’Aquila
Ospedale "Sant'Andrea"
Lamezia Terme
Ospedale Civile di Legnano
Legnano
P.O. di Livorno
Livorno
Ospedale "Umberto I°" di Lugo
Lugo
Azienda Ospedaliera "Carlo Poma"
Mantua
Ospedale Fatebenefratelli e Oftalmico
Milan
Ospedali Riuniti Padova Sud
Monselice
AORN "A. Cardarelli"
Naples
Ospedale "Vincenzo Monaldi" - AOS dei Colli
Naples
Ospedale "Umberto I°" di Nocera
Nocera Inferiore
AOU "Maggiore della Carità"
Novara
Ospedale "Buccheri-La Ferla" Fatebenefratelli
Palermo
Ospedale Di Camerino
Province of Macerata
Ospedale "Santa Maria delle Croci"
Ravenna
Isola Tiberina Gemelli-Isola Hospital, Rome
Roma
Ospedale "S. Maria della Misericordia"
Rovigo
Ospedale "Girolamo Fracastoro"
San Bonifacio
P.O. "SS. Annunziata"
Sassari
Ospedale "San Paolo"
Savona
Ospedale "Umberto I°" di Siracusa
Syracuse
Ospedale Civile "Giuseppe Mazzini"
Teramo
Ospedale di Circolo di Varese
Varese
Ospedale Civile di Voghera
Voghera
About this study
Official title: A Prospective Observational Multicenter Study of the 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.
- Conditions
- Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis, Liver Stiffness, Hepatic Encephalopathy
- Keywords
- Cirrhoses, Liver, Hepatic Encephalopathy, Internal Medicine
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patientis with diagnosis of liver cirrhosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hepatic encephalopathy
Incidence of both minimal and overt hepatic encephalopathy in patients with liver cirrhosis
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Rate of screening for minimal hepatic encephalopathy
Rate of screening for minimal hepatic encephalopathy
Measured: through study completion, an average of 1 year
Rates of in-hospital mortality
Rates of in-hospital mortality, 3-month and 9-month mortality
Measured: from the the discharge untill 9 months
Readmission rates
3-month and 9-month readmission rates post-discharge
Measured: from the the discharge untill 9 months
Rates of counseling
Rates of counseling at discharge
Measured: at discharge
Description of the treatments for overt hepatic encephalopathy
Description of the treatments for overt hepatic encephalopathy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start5 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhoses, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PAOLA PICCOLO, Principal investigator, Internal Medicine Dept. Isola Tiberina Gemelli-Isola Hospital, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727070
- Sponsor's protocol ID
- FADOI.02.2025
- Acronym
- HEPTAGON
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Multicenter Study of the Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
- ClinicalTrials.gov ID
- NCT07727070
- Acronym / sponsor ID
- HEPTAGON / FADOI.02.2025
- Conditions
- Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis, Liver Stiffness, Hepatic Encephalopathy
- Keywords
- Cirrhoses, Liver, Hepatic Encephalopathy, Internal Medicine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patientis with diagnosis of liver cirrhosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalization in Internal Medicine
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient enrolled in other non-observational clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Rate of screening for minimal hepatic encephalopathy
Time frame: through study completion, an average of 1 year
Rates of in-hospital mortality
Time frame: from the the discharge untill 9 months
Readmission rates
Time frame: from the the discharge untill 9 months
Rates of counseling
Time frame: at discharge
Description of the treatments for overt hepatic encephalopathy
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PAOLA PICCOLO principal investigator
Internal Medicine Dept. Isola Tiberina Gemelli-Isola Hospital, Rome
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhoses, Liver and Portal Hypertension Related to Cirrhosis, run by Fadoi Foundation, Italy at 41 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hepatic encephalopathy (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.