Heart FailureNCT07222813
Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)
A study testing FibroScan, Right-sided Heart Catheterization and Transthoracic echocardiography in people with Heart Failure and Heart Failure - NYHA II - IV, run by Echosens at 7 sites in 4 countries.
Trial summary
This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with procedural risks and limited applicability in certain participant populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure - NYHA II - IV
- What is being tested?
- FibroScan, Right-sided Heart Catheterization and Transthoracic echocardiography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 23 Apr 2026to 15 Jan 2028
- Phase
- Interventional
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
- Have read, understood, and signed the informed consent form (ICF)
- Be ≥18 years of age at the time of screening
- Have suspected or diagnosed acute or chronic HF and be scheduled to undergo right-sided cardiac catheterization
Who cannot join
- Inability to consent
- Chronic liver disease (self-reported alcohol use >14 drinks/week in females and >21 drinks/week in males), positive hepatitis C virus serology, positive hepatitis B surface antigen, autoimmune hepatitis, hemochromatosis, or cholestatic disease)
- BMI >40 kg/m2
- Fontan-type circulation
- Ascites
- Heart transplantation
- Pregnancy, breastfeeding, or intent to become pregnant during the study
- Intent to donate/bank or retrieve eggs (ova, oocytes) or donate sperm during the study
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
United States4 sites, 4 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Michele Esposito, MD, 843-792-1105, espositm@musc.edu
- Recruiting
University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 Location
Dallas, Texas, 75390
Ambarish Pandey, MD, MSCS, FAHA, 214-645-2101, ambarish.pandey@utsouthwestern.edu
- Not yet recruiting
Keck Medicine of USC-Norris Healthcare Center - Transplant Clinic
Los Angeles, California, 90033
Michael Fong, MD, michael.fong@usc.edu
- Recruiting
University of Minnesota
Minneota, Minnesota, 55455
Tamas Alexy, MD, 612-626-1240, alexy001@umn.edu
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
Rennes, Ile Et Vilaine, 35000
Erwan Donal, MD, 33617708567, erwan.donal@chu-rennes.fr
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum der Charité (DHZC) - Klinik fuer Herz-, Thorax- und Gefaesschirurgie
Berlin, 13353
Felix Schoenrath, MD, 4.93046E+11, felix.schoenrath@dhzc-charite.de
Poland1 site, 1 recruiting
- Recruiting
Uniwersytet Medyczny im. Piastow Slaskich we Wroclawiu, Instytut Chorob Serca
Wroclaw, Basse-Silésie
Jan Biegus, MD, 48606674114, janbiegus@gmail.com
About this study
Official title: Performance of Liver Stiffness Measurement (LSM) by FibroScan® for the Diagnosis of Elevated Central Venous Pressure (CVP)
This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with procedural risks and limited applicability in certain participant populations.
Read the detailed description
CHF, as defined by the American College of Cardiology and the American Heart Association, is "a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood." These patients will often develop congestion that may require urgent hospitalization, especially if pulmonary congestion is present. However, congestion can be difficult to assess, especially when symptoms are mild, or in patients nearing discharge from an HF hospitalization.8 Increased cardiac filling pressures, including the CVP, often silently precede the appearance of congestive symptoms by days resulting in hepatic congestion.
Invasive methods, such as RHC, remain the gold standard method of measuring CVP, offering accurate and direct hemodynamic data. However, RHC requires specialized training and invasive vascular access and is associated with procedural risks including bleeding, infection, arrhythmia, and patient discomfort.
Echocardiography is the most common non-invasive adjunct tool for estimating CVP and assessing cardiac function. It evaluates indirect parameters, right atrial size, IVC diameter, and collapsibility to detect elevated CVP.
LSM by VCTE™ has emerged as a novel non-invasive approach to detecting elevated CVP indirectly. Liver elastography relies on imaging techniques to assess LSM, with high values equating to increased stiffness. While this was developed to assess fibrosis in chronic liver diseases, LSM also reflects increased CVP and hepatic congestion. Multiple studies have shown promising correlations between increased liver stiffness and invasively measured CVP, indicating a potential clinical strategy for detecting hemodynamic congestion non-invasively.
Given these considerations, the current clinical investigation aims to evaluate the 13.3 kPa cutoff performance of LSM with FibroScan (Echosens, Paris, France) to diagnose elevated CVP (>10 mm Hg).
- Conditions
- Heart Failure, Heart Failure - NYHA II - IV
- Being tested
- FibroScan, Right-sided Heart Catheterization, Transthoracic echocardiography, Blood Sample Analysis
- Keywords
- Fibroscan, Vibration Control Transient Elastography, Liver Stiffness Measurement, Guided VCTE
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScanDevice
At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)
Right-sided Heart CatheterizationProcedure or surgery
at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)
Transthoracic echocardiographyProcedure or surgery
at Day 0 assessment of cardiac function
Blood Sample AnalysisBiological
At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests
| Study group | Role | What they receive |
|---|---|---|
| Full Cohort | Experimental | This population will be defined by patients fulfilling all inclusion and exclusion criteria. Receives: Device: FibroScan; Procedure: Right-sided Heart Catheterization; Procedure: Transthoracic echocardiography; Biological: Blood Sample Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity]
Sensitivity (true positive rate) = TP / (TP + FN)
Measured: at Day 0
Proportion of individuals without elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Specificity]
Specificity (1 - false negative rate) = TN / (TN + FP)
Measured: at Day 0
Secondary outcomes (8)
Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of elevated CVP (>10 mm Hg)
Measured: at Day 0
Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of abnormal IVC diameter
Measured: at Day 0
Logistic regression model to identify clinical, laboratory, and echocardiographic factors associated with LSM/CVP discordance.
Measured: at Day 0
Correlation between LSM and echocardiographic parameters evaluated with Pearson or Spearman correlation coefficients
- Unit of measure: Pearson or Spearman coefficient
- Measurement tool: linear regression
Measured: at Day 0
Correlation between LSM and NT-proBNP evaluated with Pearson or Spearman correlation coefficients
- Unit of measure: Pearson or Spearman coefficient
- Measurement tool: linear regression
Measured: at Day 0
Correlation between LSM and CA-125 evaluated with Pearson or Spearman correlation coefficients
- Unit of measure: Pearson or Spearman coefficient
- Measurement tool: linear regression
Measured: at Day 0
Correlation between LSM and clinical parameters evaluated with Pearson or Spearman correlation coefficients
- Unit of measure: Pearson or Spearman coefficient
- Measurement tool: linear regression
Measured: at Day 0
Proportion of individuals correctly identified for the diagnosis of elevated CVP (>10 mm Hg) compared between LSM, echocardiography parameter and NT-proBNP using DeLong's test for correlated ROC curves
Measured: at Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start23 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Model description
- This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation
- Masking
- None (open label)
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Echosens
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222813
- Sponsor's protocol ID
- Cs002
- Status last verified
- Oct 2025
- First submitted
- 17 Oct 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes