Acute Heart Failure (AHF)FIBROSCAFNCT07449377
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
A study testing FibroScan® in people with Acute Heart Failure (AHF), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF)
- What is being tested?
- FibroScan®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Name: Emergency Department Hospital Pitié-Salpêtrière, APHP
Paris, 75013
Amélie VROMANT, Medical doctor, +33617253512, amelie.vromant@aphp.fr
Yonathan FREUND, PU-PH, +33663549017, yonathan.freund@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Acute Heart Failure (AHF)
- Being tested
- FibroScan®
- Keywords
- Acute heart failure (AHF), Acute dyspnea, liver stiffness, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Patients presenting with acute dyspnea will undergo liver stiffness measurement Receives: Device: FibroScan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start2 Apr 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Echosens
- Responsible party
- Sponsor
- Investigators
- Amélie VROMANT, Medical Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449377
- Sponsor's protocol ID
- APHP250779
- Other IDs
- IDRCB 2025-A01532-47
- Acronym
- FIBROSCAF
- Status last verified
- Jun 2026
- First submitted
- 27 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT07449377
- Acronym / sponsor ID
- FIBROSCAF / APHP250779
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- Acute heart failure (AHF), Acute dyspnea, liver stiffness, emergency department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Echosens
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: FibroScan®Patients presenting with acute dyspnea will undergo liver stiffness measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Device | Interventional |
Primary outcome
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.
Time frame: 28 days after inclusion
1 secondary outcome
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.
Time frame: 28 days after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amélie VROMANT, Medical Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibroScan® in people with Acute Heart Failure (AHF), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie VROMANT, Medical Doctor (+33617253512, amelie.vromant@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 28 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.