Clinical trial

Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant. A Multicenter Prospective Pilot Study. (CARDIO-FIBROCIR)

Name

2023/803

Description

The aim of this multicenter prospective observational 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.

Trial arms

Trial start

2024-03-31

Estimated PCD

2025-03-31

Trial end

2027-12-31

Status

Not yet recruiting

Treatment

MRI

The examination lasts between 45 minutes and one hour. The patient lies down in the MRI tube. He is fitted with headphones that muffle the noise produced by the machine and enable him to receive instructions from the technician. Four electrodes are applied to his chest to continuously record his heartbeat. Finally, his chest is covered with a plastic plate, which receives the MRI signals needed to form the image. Acquiring an MRI image takes between 2 and 20 seconds. To ensure that image quality is not impaired by respiratory movements, images are acquired in apnea. The technician will ask the patient to hold his or her breath repeatedly throughout the examination.

Arms:

Patient with cirrhosis requiring liver transplantation

Blood sampling

Additional blood will be drawn for dosing acylcarnitines, copeptin, interleukin-6 (IL-6), LPS-Binding Protein (LBP), Phospholipid TransferProtein (PLTP)/Cholesteryl Ester Tranfer Protein (CETP) activity, and for plasma banking. The volume of blood will be 20 ml in total (5 ml for each assay) at each visit. Patients participating in this study will have 3 visits. Total blood volume will therefore be 20 x 3, or 60 ml for the 3 visits.

Arms:

Patient with cirrhosis requiring liver transplantation

Size

Primary endpoint

Primary outcome measure

sixth month-21th month after inclusion

Eligibility criteria

Inclusion Criteria: * Inclusion of cirrhotic patients when registering on the liver transplant list * 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 cardiorespiratory disease including portopulmonary hypertension and coronary artery disease * 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 * Refusal to agree to participation by signing the information and consent form as defined * 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 without health insurance * Subject being in the period of exclusion from another study or provided for by the "national volunteer file"

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-03-27

1 organization

1 product

1 indication

Organization

Centre Hospitalier Universitaire de Besancon

Product

Blood Sampling

Indication

Cirrhosis