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

NCT06327308 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-07-10

No results posted yet for this study

Summary

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.

Conditions

  • Cirrhosis

Interventions

DIAGNOSTIC_TEST

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.

BIOLOGICAL

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Thierry THEVENOT, MD, PHD · Centre Hospitalier Universitaire de Besancon

  • Delphine WEIL, MD · Centre Hospitalier Universitaire de Besancon

  • Camille BESCH, MD · CHU Strasbourg

  • Mouni BENSENANE -OUSSALAH, MD · CHRU Nancy

  • Marianne LATOURNERIE, MD · CHU Dijon

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-09-01
Completion
2027-06-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06327308 on ClinicalTrials.gov