Name: Emergency Department Hospital Pitié-Salpêtrière, APHP
Paris, 75013, France
Location status: Recruiting
Location contact
Amélie VROMANT, Medical doctor
CONTACT
Yonathan FREUND, PU-PH
CONTACT
NCT Number: NCT07449377
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, 75013, France
Location status: Recruiting
Amélie VROMANT, Medical doctor
CONTACT
Yonathan FREUND, PU-PH
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 measurement 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.
Time frame: 28 days after inclusion
Time frame: 28 days after inclusion
Time frame: 28 days after inclusion
Time frame: 28 days after inclusion
Contact information is provided by the study sponsor or research team.
Amélie VROMANT, Medical Doctor
CONTACT
Yonathan FREUND, PU-PH
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: FIBROSCAF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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