Cirrhotic cardiomyopathy and fibrosis in liver transplant candidates using cardiac MRI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter pilot study uses cardiac MRI to describe how myocardial fibrosis changes in cirrhotic patients before and after liver transplantation. It collects MRI data and inflammatory markers at baseline, around the transplant period, and at follow-up timepoints up to 12 months post-transplant or up to 21 months for non-transplanted patients. The study aims to link systemic inflammation with fibrosis and to see if transplantation reduces fibrosis by limiting bacterial translocation. Primary focus is the evolution of myocardial fibrosis percentage by MRI pre- and 12 months post-LT; secondary aims include fibrosis trajectories in non-transplanted patients and associations with inflammatory markers. Interventions are MRI imaging and blood sampling, with eligibility limited to transplant候 candidates and appropriate consents.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• CHU Besancon - Hopital Minjoz
  Besançon, France Recruiting
• CHU Dijon - Hopital François Mitterrand
  Dijon, France Recruiting
• CHRU Nancy - Hôpital de Brabois
  Nancy, France Recruiting
• CHU Strasbourg - Hopital de HautePierre
  Strasbourg, France Not yet recruiting

Study contacts

• Principal investigator: Delphine WEIL, MD — Centre Hospitalier Universitaire de Besancon
• Study coordinator: Delphine WEIL, MD, PHD
• Email: dweil@chu-besancon.fr
• Phone: +33381669457

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.