Acute Heart Failure (AHF)
Conditions
Keywords
Acute heart failure (AHF), Acute dyspnea, liver stiffness, emergency department
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.
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.
Interventions
DEVICEFibroScan®
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Echosens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
France
Contacts
CONTACTAmélie VROMANT, Medical Doctor
CONTACTYonathan FREUND, PU-PH
PRINCIPAL_INVESTIGATORAmélie VROMANT, Medical Doctor
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed