Liver CirrhosisNCT06746246
Evaluation of Remote Monitoring of Liver Cirrhosis Patients
An observational study of Liver Cirrhosis, run by Maastricht University Medical Center.
Trial summary
The goal of this longitudinal prospective study is to investigate disease course in patients with liver cirrhosis treated in hospitals that implemented a remote monitoring care pathway as part of their standard liver cirrhosis care pathway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Feb 2042
- 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: Patients of 18 years and older with a liver cirrhosis diagnosis, treated at a Gastroenterology department in one of the participating centers.
Who may be able to join
- Liver cirrhosis diagnosis, based on liver biopsy, fibroscan (elastography), radiographic imaging and/or clinical criteria according to applied guidelines at the time of inclusion
- Age 18 years or older
- Treated at Gastroenterology department
Who cannot join
- Patients who have declined participation in scientific studies.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tom Gevers, MD, PhD contact
About this study
Official title: Prospective Evaluation of Multicenter Implementation of Remote Monitoring of Liver Cirrhosis Patients
The goal of this longitudinal prospective study is to investigate disease course in patients with liver cirrhosis treated in hospitals that implemented a remote monitoring care pathway as part of their standard liver cirrhosis care pathway.
Participants will be asked to share their medical data and remote monitoring data. Therefore, this study does not contain an intervention.
- Conditions
- Liver Cirrhosis
- Keywords
- Digital health, Remote monitoring, eHealth, mHealth, Telehealth
- Medical subject headings
- Liver Cirrhosis
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 |
|---|---|---|
| 1. Standard care with remote monitoring | Liver cirrhosis patients participating in remote monitoring as part of new standard care pathway. They will give digital consent after subscription to the remote monitoring platform. Retrospective and prospective data will be gathered. Follow-up lasts 15 years, or until death. Patients participating in remote monitoring can be approached to give feedback about remote monitoring in terms of satisfaction, usability, applicability, compliance and feasibility. | |
| Standard care without remote monitoring | Liver cirrhosis patients not participating in remote monitoring. They will not be approached for informed consent and give implicit consent for data gathering unless otherwise stated in their individual electronic patient record. Retrospective and prospective data will be gathered. Follow-up lasts 15 years, or until death. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of liver related complications
Complications defined as: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy.
Measured: From enrollment to the end of follow-up at 15 years, or untill death.
Secondary outcomes (9)
Number of liver related clinical admissions
Liver related clinical admissions defined as complications related to: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy.
Measured: From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related emergency consultations
Liver related emergency consultations defined as consultations due to: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy.
Measured: From enrollment to the end of follow-up at 15 years, or untill death.
Liver transplantation
Measured: From enrollment to the end of follow-up at 15 years, or untill death.
Mortality
Measured: From enrollment to the end of follow-up at 15 years.
Number of outpatient department consultations
Physical or telephone
Measured: From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related laboratory tests
Measured: From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related radiographic images
Measured: From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related biopsies
Measured: From enrollment to the end of follow-up at 15 years, or untill death.
Percentage of completed modules in remote monitoring sessions
Measured: From enrollment to the end of follow-up at 15 years, or untill death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study startMay 2026 (estimated)
- Primary completionFeb 2040 (estimated)
- Study completionFeb 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gelre Hospitals, Noordwest Ziekenhuisgroep, Jeroen Bosch Ziekenhuis, Albert Schweitzer Hospital
- Responsible party
- Sponsor
- Investigators
- Tom Gevers, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746246
- Sponsor's protocol ID
- 2024-0284
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ganapathy D, Acharya C, Lachar J, Patidar K, Sterling RK, White MB, Ignudo C, Bommidi S, DeSoto J, Thacker LR, Matherly S, Shaw J, Siddiqui MS, Puri P, Sanyal AJ, Luketic V, Lee H, Stravitz RT, Bajaj JS. The patient buddy app can potentially prevent hepatic encephalopathy-related readmissions. Liver Int. 2017 Dec;37(12):1843-1851. doi: 10.1111/liv.13494. Epub 2017 Jul 5.
PubMed 28618192Kazankov K, Novelli S, Chatterjee DA, Phillips A, Balaji A, Raja M, Foster G, Tripathi D, Boddu R, Kumar R, Jalan R, Mookerjee RP. Evaluation of CirrhoCare(R) - a digital health solution for home management of individuals with cirrhosis. J Hepatol. 2023 Jan;78(1):123-132. doi: 10.1016/j.jhep.2022.08.034. Epub 2022 Sep 8.
PubMed 36087864de Jong MJ, van der Meulen-de Jong AE, Romberg-Camps MJ, Becx MC, Maljaars JP, Cilissen M, van Bodegraven AA, Mahmmod N, Markus T, Hameeteman WM, Dijkstra G, Masclee AA, Boonen A, Winkens B, van Tubergen A, Jonkers DM, Pierik MJ. Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial. Lancet. 2017 Sep 2;390(10098):959-968. doi: 10.1016/S0140-6736(17)31327-2. Epub 2017 Jul 14.
PubMed 28716313Karlsen TH, Sheron N, Zelber-Sagi S, Carrieri P, Dusheiko G, Bugianesi E, Pryke R, Hutchinson SJ, Sangro B, Martin NK, Cecchini M, Dirac MA, Belloni A, Serra-Burriel M, Ponsioen CY, Sheena B, Lerouge A, Devaux M, Scott N, Hellard M, Verkade HJ, Sturm E, Marchesini G, Yki-Jarvinen H, Byrne CD, Targher G, Tur-Sinai A, Barrett D, Ninburg M, Reic T, Taylor A, Rhodes T, Treloar C, Petersen C, Schramm C, Flisiak R, Simonova MY, Pares A, Johnson P, Cucchetti A, Graupera I, Lionis C, Pose E, Fabrellas N, Ma AT, Mendive JM, Mazzaferro V, Rutter H, Cortez-Pinto H, Kelly D, Burton R, Lazarus JV, Gines P, Buti M, Newsome PN, Burra P, Manns MP. The EASL-Lancet Liver Commission: protecting the next generation of Europeans against liver disease complications and premature mortality. Lancet. 2022 Jan 1;399(10319):61-116. doi: 10.1016/S0140-6736(21)01701-3. Epub 2021 Dec 2. No abstract available.
PubMed 34863359
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Multicenter Implementation of Remote Monitoring of Liver Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT06746246
- Acronym / sponsor ID
- 2024-0284
- Conditions
- Liver Cirrhosis
- Keywords
- Digital health, Remote monitoring, eHealth, mHealth, Telehealth
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Gelre Hospitals, Noordwest Ziekenhuisgroep, Jeroen Bosch Ziekenhuis, Albert Schweitzer Hospital
- Study start
- May 2026 (estimated)
- Primary completion
- Feb 2040 (estimated)
- Study completion
- Feb 2042 (estimated)
- First posted
- 24 Dec 2024 (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.
The goal of this longitudinal prospective study is to investigate disease course in patients with liver cirrhosis treated in hospitals that implemented a remote monitoring care pathway as part of their standard liver cirrhosis care pathway.
Participants will be asked to share their medical data and remote monitoring data. Therefore, this study does not contain an intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Standard care with remote monitoring | – | –Liver cirrhosis patients participating in remote monitoring as part of new standard care pathway. They will give digital consent after subscription to the remote monitoring platform. Retrospective and prospective data will be gathered. Follow-up lasts 15 years, or until death. Patients participating in remote monitoring can be approached to give feedback about remote monitoring in terms of satisfaction, usability, applicability, compliance and feasibility. |
| Standard care without remote monitoring | – | –Liver cirrhosis patients not participating in remote monitoring. They will not be approached for informed consent and give implicit consent for data gathering unless otherwise stated in their individual electronic patient record. Retrospective and prospective data will be gathered. Follow-up lasts 15 years, or until death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of 18 years and older with a liver cirrhosis diagnosis, treated at a Gastroenterology department in one of the participating centers.
Key inclusion criteria (3 listed)
- Liver cirrhosis diagnosis, based on liver biopsy, fibroscan (elastography), radiographic imaging and/or clinical criteria according to applied guidelines at the time of inclusion
- Age 18 years or older
- Treated at Gastroenterology department
Key exclusion criteria (1 listed)
- Patients who have declined participation in scientific studies.
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
Number of liver related complications
Time frame: From enrollment to the end of follow-up at 15 years, or untill death.
Complications defined as: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy.
9 secondary outcomes
Number of liver related clinical admissions
Time frame: From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related emergency consultations
Time frame: From enrollment to the end of follow-up at 15 years, or untill death.
Liver transplantation
Time frame: From enrollment to the end of follow-up at 15 years, or untill death.
Mortality
Time frame: From enrollment to the end of follow-up at 15 years.
Number of outpatient department consultations
Time frame: From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related laboratory tests
Time frame: From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related radiographic images
Time frame: From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related biopsies
Time frame: From enrollment to the end of follow-up at 15 years, or untill death.
Percentage of completed modules in remote monitoring sessions
Time frame: From enrollment to the end of follow-up at 15 years, or untill death.
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 26 Sep 2025.
- Background: PubMed 28618192Ganapathy D, Acharya C, Lachar J, Patidar K, Sterling RK, White MB, Ignudo C, Bommidi S, DeSoto J, Thacker LR, Matherly S, Shaw J, Siddiqui MS, Puri P, Sanyal AJ, Luketic V, Lee H, Stravitz RT, Bajaj JS. The patient buddy app can potentially prevent hepatic encephalopathy-related readmissions. Liver Int. 2017 Dec;37(12):1843-1851. doi: 10.1111/liv.13494. Epub 2017 Jul 5.
- Background: PubMed 36087864Kazankov K, Novelli S, Chatterjee DA, Phillips A, Balaji A, Raja M, Foster G, Tripathi D, Boddu R, Kumar R, Jalan R, Mookerjee RP. Evaluation of CirrhoCare(R) - a digital health solution for home management of individuals with cirrhosis. J Hepatol. 2023 Jan;78(1):123-132. doi: 10.1016/j.jhep.2022.08.034. Epub 2022 Sep 8.
- Background: PubMed 28716313de Jong MJ, van der Meulen-de Jong AE, Romberg-Camps MJ, Becx MC, Maljaars JP, Cilissen M, van Bodegraven AA, Mahmmod N, Markus T, Hameeteman WM, Dijkstra G, Masclee AA, Boonen A, Winkens B, van Tubergen A, Jonkers DM, Pierik MJ. Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial. Lancet. 2017 Sep 2;390(10098):959-968. doi: 10.1016/S0140-6736(17)31327-2. Epub 2017 Jul 14.
- Background: PubMed 34863359Karlsen TH, Sheron N, Zelber-Sagi S, Carrieri P, Dusheiko G, Bugianesi E, Pryke R, Hutchinson SJ, Sangro B, Martin NK, Cecchini M, Dirac MA, Belloni A, Serra-Burriel M, Ponsioen CY, Sheena B, Lerouge A, Devaux M, Scott N, Hellard M, Verkade HJ, Sturm E, Marchesini G, Yki-Jarvinen H, Byrne CD, Targher G, Tur-Sinai A, Barrett D, Ninburg M, Reic T, Taylor A, Rhodes T, Treloar C, Petersen C, Schramm C, Flisiak R, Simonova MY, Pares A, Johnson P, Cucchetti A, Graupera I, Lionis C, Pose E, Fabrellas N, Ma AT, Mendive JM, Mazzaferro V, Rutter H, Cortez-Pinto H, Kelly D, Burton R, Lazarus JV, Gines P, Buti M, Newsome PN, Burra P, Manns MP. The EASL-Lancet Liver Commission: protecting the next generation of Europeans against liver disease complications and premature mortality. Lancet. 2022 Jan 1;399(10319):61-116. doi: 10.1016/S0140-6736(21)01701-3. Epub 2021 Dec 2. No abstract available.
- Foundation for collaborative development of e-Health tools for different chronic diseases.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tom Gevers, MD, PhD contact
Tom Gevers, MD, PhD principal investigator
Maastricht University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Maastricht University Medical Center.
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: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Britt van Ruijven, MD (+31883887470, britt.vanruijven@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of liver related complications (time frame: From enrollment to the end of follow-up at 15 years, or untill death.). 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 NCT06746246, which also lists 4 linked publications.
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 26 Sep 2025.