Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Heart Failure - NYHA II - IV
• Intervention / Treatment: Device: FibroScan; Procedure: Right-sided Heart Catheterization; Procedure: Transthoracic echocardiography; Biological: Blood Sample Analysis

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).

• Study Type: Interventional
• Enrollment (Estimated): 149
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CAROLE MEILLEROUX, PharmD; Phone Number: +33622649277; Email: carole.meilleroux@echosens.com

Study Locations

• France
  • Ile Et Vilaine
    • Rennes, Ile Et Vilaine, France, 35000
      • Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
      • Contact: Erwan Donal, MD; Phone Number: 33617708567; Email: erwan.donal@chu-rennes.fr
• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum der Charité (DHZC) - Klinik fuer Herz-, Thorax- und Gefaesschirurgie
    • Contact: Felix Schoenrath, MD; Phone Number: 4.93046E+11; Email: felix.schoenrath@dhzc-charite.de
• Poland
  • Basse-Silésie
    • Wroclaw, Basse-Silésie, Poland
      • Uniwersytet Medyczny im. Piastow Slaskich we Wroclawiu, Instytut Chorob Serca
      • Contact: Jan Biegus, MD; Phone Number: 48606674114; Email: janbiegus@gmail.com
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medicine of USC-Norris Healthcare Center - Transplant Clinic
      • Contact: Michael Fong, MD; Email: michael.fong@usc.edu
  • Minnesota
    • Minneota, Minnesota, United States, 55455
      • University of Minnesota
      • Contact: Tamas Alexy, MD; Phone Number: 612-626-1240; Email: alexy001@umn.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
      • Contact: Michele Esposito, MD; Phone Number: 843-792-1105; Email: espositm@musc.edu
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 Location
      • Contact: Ambarish Pandey, MD, MSCS, FAHA; Phone Number: 214-645-2101; Email: ambarish.pandey@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Have read, understood, and signed the informed consent form (ICF)
2. Be ≥18 years of age at the time of screening
3. Have suspected or diagnosed acute or chronic HF and be scheduled to undergo right-sided cardiac catheterization

Exclusion Criteria:

1. Inability to consent
2. 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)
3. BMI >40 kg/m2
4. Fontan-type circulation
5. Ascites
6. Heart transplantation
7. Pregnancy, breastfeeding, or intent to become pregnant during the study
8. Intent to donate/bank or retrieve eggs (ova, oocytes) or donate sperm during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Full Cohort; This population will be defined by patients fulfilling all inclusion and exclusion criteria.

Device: FibroScan; At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM); Procedure: Right-sided Heart Catheterization; at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP); Procedure: Transthoracic echocardiography; at Day 0 assessment of cardiac function; Biological: Blood Sample Analysis; At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	at Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of elevated CVP (>10 mm Hg)		at Day 0
Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of abnormal IVC diameter		at Day 0
Logistic regression model to identify clinical, laboratory, and echocardiographic factors associated with LSM/CVP discordance.		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	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	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	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	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		at Day 0

Other Outcome Measures

Outcome Measure	Time Frame
Number of patient presenting at least one adverse event	7 days

Collaborators and Investigators

• Sponsor: Echosens
• Collaborators: Syneos Health

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: October 17, 2025
• First Submitted That Met QC Criteria: October 28, 2025
• First Posted (Estimated): October 30, 2025

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Fibroscan; Liver Stiffness Measurement; Vibration Control Transient Elastography; Guided VCTE
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: Cs002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No