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NOT YET RECRUITING
NCT06327308

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

Sponsor: Centre Hospitalier Universitaire de Besancon

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2024-09-01

Completion Date

2027-06-01

Last Updated

2024-07-10

Healthy Volunteers

No

Conditions

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.

Locations (4)

CHU Besancon - Hopital Minjoz

Besançon, France

CHU Dijon - Hopital François Mitterrand

Dijon, France

CHRU Nancy - Hôpital de Brabois

Nancy, France

CHU Strasbourg - Hopital de HautePierre

Strasbourg, France