Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre Hospitalier Universitaire de Besancon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
MRI
Diagnostic testThe 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/VaccineAdditional 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Transplanted PatientsActive comparator 2 interventions
Group B: Non Transplanted PatientsPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Primary outcome measure
Difference in myocardial extracellular volume (MECV) on cardiac MRI between the pre-LT visit (visit 2) and 12 months after LT (visit 3). If patients are transplanted less than 6 months after the inclusion visit, visit 2 will not be performed and the reference visit will be visit 1.
Time frame
sixth month-21th month after inclusionSecondary outcomes
1
Prevalence of cirrhotic cardiomyopathy according to 2019 criteria [Izzy M, et al. Hepatology 2020;71:334-45], echocardiographic signs of left ventricular systolic and diastolic dysfunction :
* Systolic dysfunction: left ventricular ejection fraction ≤ 50% and/or absolute value of left ventricular global longitudinal strain value \< 18%. * Diastolic dysfunction if ≥ 3 criteria among the following: * Mitral e' wave velocity \< 7 cm/s ; * Mitral e' wave / E wave ratio ≥ 15 ; * Indexed left atrial volume \> 34 mL/m² ; * Tricuspid regurgitation velocity \> 2.8 m/s.
Time frame
33 months2
Analysis of the association between myocardial extracellular volume (MECV) (explained variable) and plasma 3-HM concentration (explanatory variable).
The concentration of 3-hydroxy-myristate will be in pg/ml. Analysis of the association between myocardial extracellular volume (MECV) (explained variable) and plasma 3-HM concentration (explanatory variable) will be based on the observation of the point cloud.
Time frame
33 months3
Analysis of the association between myocardial extracellular volume (MECV) and the concentration of markers of inflammation (CRP, procalcitonin, copeptin, IL-6) and proteins modulating the degree of inflammation (LBP, PLTP, CETP).
Analysis of the association between myocardial extracellular volume (MECV) and the concentration of markers of inflammation (CRP, procalcitonin, copeptin, IL-6) and proteins modulating the degree of inflammation (LBP, PLTP, CETP) will be based on the observation of the point cloud.
Time frame
33 months4
Analysis of the association between the difference in MECV in transplant recipients between visit 2 and visit 3 according to the degree of immunosuppression, measured by mean residual tacrolemia in the 12 months post-LT.
Time frame
sixth month-21th month after inclusionSponsors and contacts
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Source ClinicalTrials.gov