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

Study acronym: CARDIOFIBROCIR
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Phase: Not specified to Phase 1v4 Show 7 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Sep 1, 2025 to Mar 11, 2027
    • Start date changed from estimate of Sep 1, 2024 to Mar 11, 2025
    • Study completion date: Jun 1, 2027 to Dec 11, 2029
    • Eligibility criteria revised
    • Site details revised at 4 of 4 sites
    • Study arms: 1 to 2
  2. Start date: Mar 31, 2024 to Sep 1, 2024
    • Primary completion date: Mar 31, 2025 to Sep 1, 2025
    • Study completion date: Dec 31, 2027 to Jun 1, 2027
    v3
  3. Secondary endpoints revised (6)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06327308
Lead Sponsor Centre Hospitalier Universitaire de Besancon
Conditions
(from sponsor)		 Cirrhosis, Registered on Transplant List
Related terms Fibrosis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov