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

NCT07449377 | Not Yet Recruiting

• 2 other identifiers: APHP250779IDRCB 2025-A01532-47
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Heart Failure (AHF)

Keywords

Acute heart failure (AHF); Acute dyspnea; liver stiffness; emergency department

Outcome Measures

Primary Outcomes (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.

  28 days after inclusion

Secondary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Interventional

EXPERIMENTAL

Patients presenting with acute dyspnea will undergo liver stiffness measurement

Device: FibroScan®

Interventions

FibroScan® DEVICE

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.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Echosens: collaborator

Study Sites (1)

Name: Emergency Department Hospital Pitié-Salpêtrière, APHP

Paris, 75013, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amélie VROMANT, Medical Doctor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie VROMANT, Medical Doctor

CONTACT

+33617253512; amelie.vromant@aphp.fr

Yonathan FREUND, PU-PH

CONTACT

+33663549017; yonathan.freund@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

FR (1)