Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant.
Key facts
- Who runs it
- Centre Hospitalier Universitaire de Besancon
- Where
- France4 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 60 people, planned
- Started
- 11 Mar 2025
- Expected to end
- 11 Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- MRI
- Blood sampling
- Record updated
- 22 July 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- Inclusion of cirrhotic patients who are candidates for liver transplantation and without documented contraindications to transplantation
- Women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
- Signature of an informed consent form indicating that the subject has understood the purpose and procedures required by the study and that he or she agrees to participate in the study and to comply with the requirements and restrictions inherent in the study
- Patient with a social security system or beneficiary of such a system
Who cannot take part
- Transplant Patient
- Known heart disease including portopulmonary hypertension and coronary artery disease (history of ischemic heart disease with necrosis, history of cardiomyopathy or acute myocarditis)
- Uncontrolled hypertension with interventricular septal thickness ≥ 15 mm
- Type 1 diabetes
- Current bacterial infection
- HIV infection (or unknown HIV status)
- Contraindications for MRI including pacemaker, implantable defibrillators, electrosystolic pacing probe, Swan-Ganz probe, postoperative epicardial electrodes, Starr-Ewards metal ball valves, insulin pumps, ferromagnetic vascular clips, ocular and otological implants, ocular ferromagnetic foreign bodies, renal failure with a GFR \< 30 mL/min/1.73 m², contraindication to contrast media, patient unable to maintain apnea for a few seconds, claustrophobia
- Minor or over 70 years old
- Patient with a TIPS
- Hemodynamic instability
- Inability to receive informed information in patients with severe encephalopathy who do not have a trusted person
- Patient under guardianship, curatorship, Legal incapacity or limited legal capacity
- Patient deprived of liberty
- Pregnant woman or breastfeeding
- Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
- Subject being in the period of exclusion from another study or provided for by the "national volunteer file"
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The aim of this multicenter prospective interventional pilot study is to describe the evolution of myocardial fibrosis in cirrhotic patients before and after liver transplantation (LT). Through multimodal analysis of myocardial function and architecture, and analysis of specific markers of inflammation, we aim to explore the following hypotheses: 1) systemic inflammation promotes myocardial fibrosis in cirrhotic patients and could be an early marker of cirrhotic cardiomyopathy; 2) LT allows resolution of myocardial fibrosis by preventing the bacterial translocation that favors the development of deleterious systemic inflammation.
The 2 groups in the trial
- Transplanted PatientsExisting treatment, for comparison
Patients who received a liver transplant.
Treatment: MRI and Blood sampling
- Non Transplanted PatientsPlacebo, for comparison
Patient who does not receive liver transplantation (Out of list due to the appearance of a contraindication to liver transplantation).
Treatment: MRI and Blood sampling
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant. A Multicenter Prospective Pilot Study. (CARDIO-FIBROCIR)
- Fit questions
- Built from NCT06327308, who can take part
- Record updated
- 22 July 2026