Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327308
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-18
Brief Title:
Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant A Multicenter Prospective Pilot Study CARDIO-FIBROCIR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARDIOFIBROCIR
Brief 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
Detailed Description:
Cirrhotic patients with an indication for LT and undergoing pre-transplant assessment will be eligible for this study All included patients will undergo myocardial Magnetic Resonance Imaging MRI at the time of inclusion then at a second visit that will be planned as close as possible to the expected date of LT or at 9 months in the absence of LT then 12 months after LT or 21 months after inclusion for non-transplanted patients Markers of systemic inflammation will be analyzed at these same time points
Primary outcome to describe the evolution of the percentage of myocardial fibrosis on cardiac MRI before and 12 months after LT in cirrhotic patients
Secondary outcomes
1 To describe the evolution of the percentage of myocardial fibrosis at 9 months and 21 months in non-transplanted patients
2 To estimate the prevalence of cirrhotic cardiomyopathy in cirrhotic patients before and 12 months after LT
3 To describe the relationship between plasma 3-hydroxymyristate 3-HM concentration and the level of myocardial fibrosis estimated by myocardial extracellular volume MECV before and 12 months after LT
4 To describe the relationship between several markers of inflammation CRP procalcitonin copeptin IL-6 or proteins modulating the degree of inflammation LPS-binding protein LPB Phospholipid Transfer Protein PLTP Cholesteryl Ester Transfer Protein CETP and the level of myocardial fibrosis estimated by MECV before and 12 months after LT
5 To describe in liver transplanted patients the evolution of the percentage of myocardial fibrosis before and 12 months after LT according to the degree of immunosuppression
6 To describe in liver transplanted patients the occurrence of cardiovascular events according to the cirrhotic cardiomyopathy status from inclusion ie placement on the transplant waiting list to transplantation
7 To describe the occurrence of cardiovascular events according to the cirrhotic cardiomyopathy status in the 12 months following LT
Primary outcome to describe the evolution of the percentage of myocardial fibrosis on cardiac MRI before and 12 months after LT in cirrhotic patients
Secondary outcomes
1 To describe the evolution of the percentage of myocardial fibrosis at 9 months and 21 months in non-transplanted patients
2 To estimate the prevalence of cirrhotic cardiomyopathy in cirrhotic patients before and 12 months after LT
3 To describe the relationship between plasma 3-hydroxymyristate 3-HM concentration and the level of myocardial fibrosis estimated by myocardial extracellular volume MECV before and 12 months after LT
4 To describe the relationship between several markers of inflammation CRP procalcitonin copeptin IL-6 or proteins modulating the degree of inflammation LPS-binding protein LPB Phospholipid Transfer Protein PLTP Cholesteryl Ester Transfer Protein CETP and the level of myocardial fibrosis estimated by MECV before and 12 months after LT
5 To describe in liver transplanted patients the evolution of the percentage of myocardial fibrosis before and 12 months after LT according to the degree of immunosuppression
6 To describe in liver transplanted patients the occurrence of cardiovascular events according to the cirrhotic cardiomyopathy status from inclusion ie placement on the transplant waiting list to transplantation
7 To describe the occurrence of cardiovascular events according to the cirrhotic cardiomyopathy status in the 12 months following LT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None