Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department (FIBROSCAF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Heart Failure (AHF)
• Intervention / Treatment: Device: FibroScan®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yonathan FREUND, PU-PH; Phone Number: +33663549017; Email: yonathan.freund@aphp.fr
• Study Contact Backup: Name: Amélie VROMANT, Medical doctor; Phone Number: +33617253512; Email: amelie.vromant@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Name: Emergency Department Hospital Pitié-Salpêtrière, APHP
    • Contact: Yonathan FREUND, PU-PH; Phone Number: +33663549017; Email: yonathan.freund@aphp.fr
    • Contact: Amélie VROMANT, Medical doctor; Phone Number: +33617253512; Email: amelie.vromant@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients ≥18 years
2. ED patients presenting with acute dyspnea and absence of any other obvious cause of dyspnea (for example pneumothorax, acute pneumonia, acute coronary syndrome, Covid) …
3. Social security affiliation (except AME)
4. Informed consent signed

Exclusion Criteria:

1. Known chronic liver disease, defined by a Prothrombic time of < 50%, or any former diagnosis of liver fibrosis.
2. No skin wounds in the abdominal area on which the Fibroscan® will be used
3. History of liver transplantation
4. eGFR <30 mL/min
5. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
6. Pregnancy and breastfeeding
7. Participation in another interventional trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Interventional; Patients presenting with acute dyspnea will undergo liver stiffness measurement

Device: FibroScan®; The patient will then receive standard medical care, including blood tests and imaging as needed. Once inclusion is confirmed, the patient will undergo a liver stiffness measurement with the Fibroscan® device(Class IIa medical device, CE marked for off-label us) , and the results, including a computed score, will be documented on a separate sheet. The measureemnt will be performed during the emergency department stay without delaying the initiation of any necessary treatment. The remainder of the patient's management will proceed as per standard care protocols. The assessment of liver stiffness will be performed before results of blood test and imaging studies. Patients will be followed up until hospital discharge or 28-day days post-admission, whichever comes first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	28 days after inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Association between the Liver Stiffness Measurement (LSM) and the score of congestion according to a validated clinical congestion score that ranges from 0 to 9.	28 days after inclusion

Other Outcome Measures

Outcome Measure	Time Frame
Association between hospital mortality, hospital length of stay, and adverse events with the Liver Stiffness Measurement (LSM) will also be collected.	28 days after inclusion
Adverse events with the Liver Stiffness Measurement (LSM)	28 days after inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Echosens
• Investigators: Principal Investigator: Amélie VROMANT, Medical Doctor, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: emergency department; liver stiffness; Acute dyspnea; Acute heart failure (AHF)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies
• Other Study ID Numbers: APHP250779; IDRCB 2025-A01532-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No