Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to … (NCT07449377) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
France100 participantsStarted 2026-04-02
Plain-language summary
Acute heart failure (AHF) is a major cause of acute dyspnea in emergency departments (EDs), driven primarily by venous congestion, which can lead to hepatic congestion and risk of subsequent liver dysfunction. Current diagnostic tools include clinical evaluation, biomarkers, and imaging (Chest X-Ray or echography), are often limited by delayed results, variability, and suboptimal accuracy in emergency settings.
Fibroscan®, a non-invasive device originally designed to assess liver stiffness in chronic liver conditions, has shown potential in detecting liver congestion linked to heart failure. Studies have highlighted significant correlations between liver stiffness measurements (LSM) and markers of venous congestion, such as central venous pressure and adverse outcomes in heart failure patients. Preliminary findings suggest that LSM could provide rapid, bedside insights into systemic congestion, offering a promising avenue for improving diagnostic workflows in acute care.
While prior research has mainly focused on chronic heart failure or small study populations, further investigation is needed to explore the utility of Fibroscan® in acute presentations of AHF within EDs. This could help address the limitations of existing diagnostic approaches and enhance patient management in time-sensitive environments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients ≥18 years
. ED patients presenting with acute dyspnea and absence of any other obvious cause of dyspnea (for example pneumothorax, acute pneumonia, acute coronary syndrome, Covid) …
. Social security affiliation (except AME)
. Informed consent signed
Exclusion criteria
. Known chronic liver disease, defined by a Prothrombic time of \< 50%, or any former diagnosis of liver fibrosis.
. No skin wounds in the abdominal area on which the Fibroscan® will be used
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether a liver stiffness scan called FibroScan can help diagnose acute heart failure in the emergency department — how does that approach compare to the tests you'd normally use to diagnose my condition, and could it change how quickly I get a diagnosis?
2Since this study is listed as 'not yet recruiting,' do you know when it's expected to open, and would waiting to participate affect the timing of my treatment in any way?
3This trial is described as Phase NA, which suggests it's a diagnostic accuracy study rather than a treatment trial — does that mean there's no experimental therapy involved, and what would my care look like if I took part compared to standard treatment?
4The study is measuring how well FibroScan identifies acute heart failure using something called the AUC ROC — can you explain in plain terms what that means for how reliable this test would actually be in a real emergency situation like mine?
5If I were to consider enrolling once this trial opens, what would participation actually require of me during what is already a stressful emergency department visit, and would it in any way delay or change the care I receive?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Area under the Receiving Operator Characteristic curve (AUC ROC) of Liver Stiffness Measurement (LSM) value to diagnose AHF. Other diagnostic performances will also be assessed at the threshold determined by Youden's method.