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New treatment option for Cirrhosis
Official title Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant.
ClinicalTrials.gov ID: NCT06327308
What this study is testing
What is Blood sampling?
Blood sampling is an investigational medicine, being studied as a potential treatment for cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
- Patient with a social security system or beneficiary of such a system.
You likely can't join if
- 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...
- Uncontrolled hypertension with interventricular septal thickness ≥ 15 mm
- Hemodynamic instability
See the full eligibility criteria
- 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...
- 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...
- Patient with a social security system or beneficiary of such a system.
- 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
- 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...
- 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"
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Dijon, France
- Nancy, France
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Dijon, France; Nancy, France; Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.