Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant.
Recruiting now · Phase 1
Conditions studied: Cirrhosis, Registered on Transplant List
In brief
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.
Key facts
- Study ID
- NCT06327308
- Run by
- Centre Hospitalier Universitaire de Besancon
- People needed
- 60
- Starts
- 2025-03-11
- Expected to finish
- 2029-12-11
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Minor or over 70 years old
- Transplant Patient
- Patient with a TIPS
- 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
- Hemodynamic instability
- 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
- 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"
Where it is running
- CHU Besancon - Hopital Minjoz — Besançon, France (enrolling)
- CHU Dijon - Hopital François Mitterrand — Dijon, France (enrolling)
- CHRU Nancy - Hôpital de Brabois — Nancy, France (enrolling)
- CHU Strasbourg - Hopital de HautePierre — Strasbourg, France
Full record on ClinicalTrials.gov
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