Cirrhosis, LiverRH7NCT04767945
Cirrhosis Registry of Hospitalized Patients
An observational study of Cirrhosis, Liver and Frailty, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 1 site in Slovakia.
Trial summary
Cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cirrhosis, Liver, Frailty, Ascites
- How many people
- 2,000 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Jul 2014to 31 Dec 2029
- How long will I take part?
- 15 Years
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Included are patients with liver cirrhosis and indication for hospital admission who are or are not candidates for liver transplant and have or do not have liver cancer
Who may be able to join
- liver cirrhosis (primarily on clinical grounds)
- decompensating event leading to hospital admission
- informed consent
Who cannot join
- declined consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
F.D.Roosevelt Teaching Hospital
Banská Bystrica, 97401
Lubomir Skladany, MD, PhD, +421905482997, lubomir.skladany@gmail.com
Natalia Bystrianska, MD, +421917944393, naty2121@centrum.sk
About this study
Official title: Registry of Adult Consenting Patients Admitted to the Liver Unit With Liver Cirrhosis
Cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit
Read the detailed description
On admission to F.D.Roosevelt Teaching Hospital / HEGITO Liver Unit (Div Hepatology, Gastroenterology and Liver Transplant), all the adult patients with liver cirrhosis are offered to participate.
After providing informed consent, their demographic, clinical and laboratory / imaging data are uploaded by dedicated study person After discharge from the hospital, follow-up is recommended and uploaded to RH7 (if the follow-up visits take place at this institution [FDR]) Mortality data are uploaded from the national registry of dead on regular basis
- Conditions
- Cirrhosis, Liver, Frailty, Ascites, Encephalopathy, Infection
- Keywords
- Cirrhosis, decompensation, frailty
- Medical subject headings
- Liver Cirrhosis, Frailty, Ascites, Brain Diseases, Infections, Fibrosis
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 |
|---|---|---|
| Adults with liver cirrhosis admitted to hospital liver unit | Consenting adults admitted with liver cirrhosis; recorded/uploaded are demographic, clinical, laboratory and imaging data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and type of decompensation of liver cirrhosis
Registrations reflect cirrhosis prevalence; decompensation are acute, chronic, or acute-on-chronic
Measured: "1 year"
Mortality
Record mortality in registered cirrhotics
Measured: "1 year"
Secondary outcomes (3)
Mortality
Record mortality in registered cirrhotics
Measured: 90-day
Mortality
Record mortality in registered cirrhotics
Measured: 1 year
Frailty
Measurement of the liver frailty index
Measured: On admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jul 2014
- Primary completion2 Feb 2021
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, 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
- 2,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ľubomír Skladaný MD, PhD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Investigators
- Lubomir Skladany, MD PhD, Principal investigator, F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767945
- Sponsor's protocol ID
- HEGITO2014
- Acronym
- RH7
- Status last verified
- Aug 2022
- First submitted
- 21 Jan 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing by request primarily by investigators from other centres, editors of medical journals, authors of meta analyses, etc
Publications
Koller T, Vrbova P, Kubanek N, Zilincanova D, Selcanova SA, Havaj DJ, Skladany L. Assessment of intestinal inflammation via fecal calprotectin for early prediction of adverse outcomes in advanced chronic liver disease. United European Gastroenterol J. 2025 Apr;13(3):305-316. doi: 10.1002/ueg2.12633. Epub 2024 Jul 19.
PubMed 39031494
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Adult Consenting Patients Admitted to the Liver Unit With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04767945
- Acronym / sponsor ID
- RH7 / HEGITO2014
- Conditions
- Cirrhosis, Liver, Frailty, Ascites, Encephalopathy, Infection
- Keywords
- Cirrhosis, decompensation, frailty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska BystricaUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Feb 2021 (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.
Cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit
Detailed description
On admission to F.D.Roosevelt Teaching Hospital / HEGITO Liver Unit (Div Hepatology, Gastroenterology and Liver Transplant), all the adult patients with liver cirrhosis are offered to participate.
After providing informed consent, their demographic, clinical and laboratory / imaging data are uploaded by dedicated study person After discharge from the hospital, follow-up is recommended and uploaded to RH7 (if the follow-up visits take place at this institution [FDR]) Mortality data are uploaded from the national registry of dead on regular basis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with liver cirrhosis admitted to hospital liver unit | – | –Consenting adults admitted with liver cirrhosis; recorded/uploaded are demographic, clinical, laboratory and imaging data |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included are patients with liver cirrhosis and indication for hospital admission who are or are not candidates for liver transplant and have or do not have liver cancer
Key inclusion criteria (3 listed)
- liver cirrhosis (primarily on clinical grounds)
- decompensating event leading to hospital admission
- informed consent
Key exclusion criteria (1 listed)
- declined consent
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
Frequency and type of decompensation of liver cirrhosis
Time frame: "1 year"
Registrations reflect cirrhosis prevalence; decompensation are acute, chronic, or acute-on-chronic
Mortality
Time frame: "1 year"
Record mortality in registered cirrhotics
3 secondary outcomes
Mortality
Time frame: 90-day
Mortality
Time frame: 1 year
Frailty
Time frame: On admission
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 3 Aug 2022.
- Derived from this study: PubMed 39031494Koller T, Vrbova P, Kubanek N, Zilincanova D, Selcanova SA, Havaj DJ, Skladany L. Assessment of intestinal inflammation via fecal calprotectin for early prediction of adverse outcomes in advanced chronic liver disease. United European Gastroenterol J. 2025 Apr;13(3):305-316. doi: 10.1002/ueg2.12633. Epub 2024 Jul 19.
- Individual participant dataSharing planned: Yes. Sharing by request primarily by investigators from other centres, editors of medical journals, authors of meta analyses, etc
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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.
Lubomir Skladany, MD PhD principal investigator
F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver and Frailty, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 1 site in Slovakia.
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: looking for participants now, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. 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?
Contact Lubomir Skladany, MD, PhD (+421905482997, lubomir.skladany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and type of decompensation of liver cirrhosis (time frame: "1 year"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767945, which also lists 1 linked publication.
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 3 Aug 2022.