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CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis

Sponsor: University College, London

NCT ID: NCT06223893

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
CirrhoCare management system (device)
How long the study runs
Study runs about 38 months (dates as stated)
About the drug or intervention
CirrhoCare management system — device: This is a UKCA-marked, digital-therapeutic system consisting of: * clinical-grade, cirrhosis monitoring sensors and a smartphone app, * a clinical team-facing, decision-facilitating dashboard, and * CyberLiver's platform incorporating hepatic algorithms.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
214
Started
2023-11-24
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for decompensated cirrhosis
  • • NA - 214 participants
  • • The CirrhoCare trial is a multi-centre, open label randomised controlled trial in patients with decompensated cirrhosis

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with decompensated cirrhosis

Where?

  • • Birmingham - Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
  • • Brighton - Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
  • • Coventry - Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
  • • Liverpool - Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
  • • +11 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The CirrhoCare trial is a multi-centre, open label randomised controlled trial in patients with decompensated cirrhosis. The trial aims to investigate the clinical and cost-effectiveness of CirrhoCare digital home monitoring and management with current standard of care in these patients.

More detail

Cirrhosis, progressive scaring of the liver- has many causes, principally, excessive alcohol intake, fatty-liver and viral infections. Unlike many chronic diseases, cirrhosis deaths are increasing rapidly year-on-year. It is the third commonest cause of premature, UK working-age deaths, with 62,000 years of working-life lost each year and NHS care costs of £4.53bn annually. One quarter of all UK cirrhosis patients are at-risk of acute decompensation, whereby complications such as fluid-overload, confusion and infections arise, requiring hospital-emergency treatment. Currently, decompensated cirrhosis patients require regular hospital clinical assessments to detect these new complications. Even following hospital discharge, readmission with new decompensating complications approaches 37% in 4 weeks. This disease burden, compounded by increasing alcohol and obesity-driven liver disease, means demand for specialist liver services outweighs current capacity in a resource-stretched healthcare system. Moreover, regional variation of specialist liver services also impacts on illness and deaths, leading to a postcode lottery of care access and geographical inequity. The CirrhoCare trial, addresses this urgent clinical-need through an innovative cirrhosis management system, including home-monitoring of decompensated cirrhosis patients, measuring vital signs such as heart rate and blood pressure (using low cost, sensing technology), assessing weight (smart-scale) and mental ability (smartphone app), all of which are impacted as cirrhosis progresses. By efficiently and securely collecting data on CyberLiver's management-system (platform), CirrhoCare provides a decision-facilitating tool, incorporating individual-patient data, helping liver-physicians to optimise and personalise treatment in the community. The CirrhoCare trial investigators also plan to assess clinical and cost effectiveness of CirrhoCare management and seek regulatory approvals. This innovative aspect of cirrhosis management will be more acceptable and convenient for patients. It will also deliver community care with environmental, sustainable benefits, through reduced hospital visits, despite increasing service demands. The cost- effectiveness analysis will generate value-for-money evidence of CirrhoCare management, and the clinical evidence needed to inform future adoption into the NHS.

Decompensated Cirrhosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
  • ✓Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C...
  • ✓Participants able to give agreement to take part.

Who cannot take part

  • ✗Participants with ACLF grade 2 and above according to the criteria published by Moreau
  • ✗Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.
  • ✗Current overt liver encephalopathy, defined as grade II-IV liver encephalopathy according to the West-Haven...
  • ✗Participants with documented refractory ascites on a palliative pathway.
  • ✗Participants who are active on the transplant waiting list.
See the full criteria
Inclusion criteria: 1. Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology. 2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. However, participants with cirrhosis due to autoimmune hepatitis must be on a stable corticosteroid dose for ≥3-month period before study inclusion (to be recorded on concomitant log). 3. Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) ≥42 points but ≤65 points at the time of screening. 4. Hospitalisation for acute decompensation \[determined as one or more of the following: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy, spontaneous bacterial peritonitis (SBP) or hepatorenal syndrome - acute kidney injury (HRS-AKI)\]. 5. Participants able to give informed consent. Exclusion criteria: 1. Participants with ACLF grade 2 and above according to the criteria published by Moreau 2. Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants. 3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent. 4. Participants with active hepatocellular carcinoma (HCC) or history of HCC that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria. 5. Participants with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD \>2, chronic kidney disease with serum creatinine \>2mg/dL or under renal replacement therapy. 6. Participants with documented refractory ascites on a palliative pathway. 7. Participants who are active on the transplant waiting list. 8. Participants with current extra hepatic malignancies including solid tumours and hematologic disorders. 9. Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study. 10. Participants with active viral infections, or yet to achieve clear response to anti-viral therapy. 11. Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses. 12. Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g., participants on an end-of-life palliative care pathway). 13. Participants enrolled in other interventional trials.

Where Is This Study? (15 UK sites)

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2GW, United Kingdom

Recruiting
Site contact (verified)
Neil RajoriyaPrincipal Investigator

Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust

Brighton BN2 5BE, United Kingdom

Recruiting
Site contact (verified)
Lucia MackenPrincipal Investigator

Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust

Coventry CV2 2DX, United Kingdom

Recruiting
Site contact (verified)
Sophia ThanPrincipal Investigator

Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

Liverpool L7 8YE, United Kingdom

Recruiting
Site contact (verified)
Omar ElshaarawyPrincipal Investigator

The Royal London Hospital, Barts Health NHS Trust

London E1 1FR, United Kingdom

Recruiting
Site contact (verified)
Vikram SharmaPrincipal Investigator

Whittington Hospital, Whittington Health NHS Trust

London N19 5NF, United Kingdom

Recruiting
Site contact (verified)
Evangelia FatourouPrincipal Investigator
Evangelia Fatourouevangelia.fatourou@nhs.net

Royal Free Hospital, Royal Free London NHS Foundation Trust

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)
Rajeshwar MookerjeePrincipal Investigator
Rajeshwar Mookerjeer.mookerjee@ucl.ac.uk

St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust

London SE1 7EH, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Giovanni TrittoPrincipal Investigator

King's College Hospital, King's College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)
Vishal PatelPrincipal Investigator

St George's Hospital, St George's university Hospital NHS Foundation Trust

London SW17 0QT, United Kingdom

Recruiting
Site contact (verified)
Daniel Fortan, ProfPrincipal Investigator

Queen's Medical Centre, Nottingham University Hospitals NHS Trust

Nottingham NG7 2UH, United Kingdom

Recruiting
Site contact (verified)
Naaventhan PalaniyappanPrincipal Investigator

John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Jeremy CobboldPrincipal Investigator

Derriford Hospital, University Hospitals Plymouth NHS Trust

Plymouth PL6 8DH, United Kingdom

Recruiting
Site contact (verified)
Ashwin DhandaPrincipal Investigator

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Mark WrightPrincipal Investigator

Torbay Hospital, Torbay and South Devon NHS Foundation Trust

Torquay TQ2 7AA, United Kingdom

Recruiting
Site contact (verified)
James NealePrincipal Investigator

How to Get in Touch

Tasheeka Jeyapalan

Sponsor contact

CONTACT

+4402076704687 cctu.cirrhocare@ucl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-04