CirrhosisPhase 1CARDIOFIBROCIRNCT06327308
Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant.
A Phase 1 study testing MRI and Blood sampling in people with Cirrhosis and Registered on Transplant List, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Registered on Transplant List
- What is being tested?
- MRI and Blood sampling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 11 Mar 2025to 11 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
- Uncontrolled hypertension with interventricular septal thickness ≥ 15 mm
- Hemodynamic instability
Show all 16Show fewer
- Type 1 diabetes
- Current bacterial infection
- HIV infection (or unknown HIV status)
- Contraindications for MRI including pacemaker, implantable defibrillators, electrosystolic pacing probe, Swan-Ganz probe, postoperative epicardial electrodes, Starr-Ewards metal ball valves, insulin pumps, ferromagnetic vascular clips, ocular and otological implants, ocular ferromagnetic foreign bodies, renal failure with a GFR \< 30 mL/min/1.73 m², contraindication to contrast media, patient unable to maintain apnea for a few seconds, claustrophobia
- Inability to receive informed information in patients with severe encephalopathy who do not have a trusted person
- Patient under guardianship, curatorship, Legal incapacity or limited legal capacity
- Patient deprived of liberty
- Pregnant woman or breastfeeding
- Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
- Subject being in the period of exclusion from another study or provided for by the "national volunteer file"
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHU Besancon - Hopital Minjoz
Besançon, 25000
Delphine WEIL, MD, PHD
- Recruiting
CHU Dijon - Hopital François Mitterrand
Dijon, 21000
Marianne LATOURNERIE, MD
- Recruiting
CHRU Nancy - Hôpital de Brabois
Nancy, 54000
Mouni BENSENANE -OUSSALAH, MD
- Not yet recruiting
CHU Strasbourg - Hopital de HautePierre
Strasbourg, 67000
Camille BESCH, MD
About this study
Official title: Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant. A Multicenter Prospective Pilot Study. (CARDIO-FIBROCIR)
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.
Read the 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
- To describe the evolution of the percentage of myocardial fibrosis at 9 months and 21 months in non-transplanted patients.
- To estimate the prevalence of cirrhotic cardiomyopathy in cirrhotic patients before and 12 months after LT.
- 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
- 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.
- 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.
- To describe, in liver transplanted patients, the occurrence of cardiovascular events according to the cirrhotic cardiomyopathy status, from inclusion (i.e., placement on the transplant waiting list) to transplantation.
- To describe the occurrence of cardiovascular events according to the cirrhotic cardiomyopathy status in the 12 months following LT.
- Conditions
- Cirrhosis, Registered on Transplant List
- Being tested
- MRI, Blood sampling
- Keywords
- Cirrhosis, cirrhotic cardiomyopathy, Liver Transplantation, MRI
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
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. These apneas must last less than 15 seconds.
Blood samplingBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Transplanted Patients | Active comparator | Patients who received a liver transplant. Receives: Diagnostic Test: MRI; Biological: Blood sampling |
| Non Transplanted Patients | Placebo comparator | Patient who does not receive liver transplantation (Out of list due to the appearance of a contraindication to liver transplantation). Receives: Diagnostic Test: MRI; Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: sixth month-21th month after inclusion
Secondary outcomes (6)
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.
Measured: 33 months
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.
Measured: 33 months
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.
Measured: 33 months
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.
Measured: sixth month-21th month after inclusion
Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) according to cirrhotic cardiomyopathy status occurring between inclusion and LT.
Measured: 33 months
Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) occurring between inclusion and LT, according to cirrhotic cardiomyopathy status.
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start11 Mar 2025
- Primary completion11 Mar 2027 (estimated)
- Study completion11 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A Multicenter Prospective Pilot Study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry THEVENOT, MD, PHD, Study director, Centre Hospitalier Universitaire de BesanconDelphine WEIL, MD, Principal investigator, Centre Hospitalier Universitaire de BesanconCamille BESCH, MD, Principal investigator, CHU StrasbourgMouni BENSENANE -OUSSALAH, MD, Principal investigator, CHRU NancyMarianne LATOURNERIE, MD, Principal investigator, CHU Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327308
- Sponsor's protocol ID
- 2023/803
- Acronym
- CARDIOFIBROCIR
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant. A Multicenter Prospective Pilot Study. (CARDIO-FIBROCIR)
- ClinicalTrials.gov ID
- NCT06327308
- Acronym / sponsor ID
- CARDIOFIBROCIR / 2023/803
- Conditions
- Cirrhosis, Registered on Transplant List
- Keywords
- Cirrhosis, cirrhotic cardiomyopathy, Liver Transplantation, MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 11 Mar 2027 (estimated)
- Study completion
- 11 Dec 2029 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- To describe the evolution of the percentage of myocardial fibrosis at 9 months and 21 months in non-transplanted patients.
- To estimate the prevalence of cirrhotic cardiomyopathy in cirrhotic patients before and 12 months after LT.
- 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
- 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.
- 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.
- To describe, in liver transplanted patients, the occurrence of cardiovascular events according to the cirrhotic cardiomyopathy status, from inclusion (i.e., placement on the transplant waiting list) to transplantation.
- To describe the occurrence of cardiovascular events according to the cirrhotic cardiomyopathy status in the 12 months following LT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Multicenter Prospective Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Transplanted Patients | Active comparator | Diagnostic Test: MRI, Biological: Blood samplingPatients who received a liver transplant. |
| Non Transplanted Patients | Placebo comparator | Diagnostic Test: MRI, Biological: Blood samplingPatient who does not receive liver transplantation (Out of list due to the appearance of a contraindication to liver transplantation). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)
- Uncontrolled hypertension with interventricular septal thickness ≥ 15 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIThe 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. | Diagnostic test | Non Transplanted Patients, Transplanted Patients |
| Blood samplingAdditional 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. | Biological | Non Transplanted Patients, Transplanted Patients |
Primary outcome
Primary outcome measure
Time frame: sixth month-21th month after inclusion
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.
6 secondary outcomes
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 :
Time frame: 33 months
Analysis of the association between myocardial extracellular volume (MECV) (explained variable) and plasma 3-HM concentration (explanatory variable).
Time frame: 33 months
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).
Time frame: 33 months
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 inclusion
Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) according to cirrhotic cardiomyopathy status occurring between inclusion and LT.
Time frame: 33 months
Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) occurring between inclusion and LT, according to cirrhotic cardiomyopathy status.
Time frame: 33 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thierry THEVENOT, MD, PHD study director
Centre Hospitalier Universitaire de Besancon
Delphine WEIL, MD principal investigator
Centre Hospitalier Universitaire de Besancon
Camille BESCH, MD principal investigator
CHU Strasbourg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRI and Blood sampling in people with Cirrhosis and Registered on Transplant List, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine WEIL, MD, PHD (+33381669457, dweil@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure (time frame: sixth month-21th month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.