Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant.

Sponsor
Centre Hospitalier Universitaire de Besancon
Study ID
NCT06327308
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cirrhosis
  • Registered on Transplant List

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • MRI — DIAGNOSTIC_TEST
    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. These apneas must last less than 15 seconds.
  • Blood sampling — BIOLOGICAL
    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.

Study Details

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 Dates

First listed
Mar 25, 2024
Start date
Mar 11, 2025
Status verified
Jul 2026
Primary completion
Mar 11, 2027
Completion
Dec 11, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Transplanted Patients
    Patients who received a liver transplant.
  • Placebo Comparator: Non Transplanted Patients
    Patient who does not receive liver transplantation (Out of list due to the appearance of a contraindication to liver transplantation).

Primary Outcome Measure

Primary outcome measure [ Time Frame: sixth month-21th month after inclusion ]

Central Contacts

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