Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Recruiting · NCT07449377 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
- History of liver transplantation
- eGFR \<30 mL/min
- Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- Pregnancy and breastfeeding
- Participation in another interventional trial
Where it is running
1 location listed.
- Name: Emergency Department Hospital Pitié-Salpêtrière, APHP - Paris, France