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

NCT07222813 | Not Yet Recruiting FDA Device

• 1 other identifier: Cs002
• Study Type: interventional
• Target: 149
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

Heart Failure; Heart Failure - NYHA II - IV

Keywords

Fibroscan; Vibration Control Transient Elastography; Liver Stiffness Measurement; Guided VCTE

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

  at Day 0

• Correlation between LSM and NT-proBNP evaluated with Pearson or Spearman correlation coefficients

  at Day 0

Other Outcomes (1)

• Number of patient presenting at least one adverse event

  7 days

Study Arms (1)

Full Cohort

EXPERIMENTAL

This population will be defined by patients fulfilling all inclusion and exclusion criteria.

Device: FibroScan; Procedure: Right-sided Heart Catheterization; Procedure: Transthoracic echocardiography; Biological: Blood Sample Analysis

Interventions

FibroScan DEVICE

At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)

Full Cohort

Right-sided Heart Catheterization PROCEDURE

at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)

Full Cohort

Transthoracic echocardiography PROCEDURE

at Day 0 assessment of cardiac function

Full Cohort

Blood Sample Analysis BIOLOGICAL

At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests

Full Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Echosens: lead
• Syneos Health: collaborator

Study Sites (7)

Keck Medicine of USC-Norris Healthcare Center - Transplant Clinic

Los Angeles, California, 90033, United States

Location

University of Minnesota

Minneota, Minnesota, 55455, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 Location

Dallas, Texas, 75390, United States

Location

Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou

Rennes, Ile Et Vilaine, 35000, France

Location

Deutsches Herzzentrum der Charité (DHZC) - Klinik fuer Herz-, Thorax- und Gefaesschirurgie

Berlin, 13353, Germany

Location

Uniwersytet Medyczny im. Piastow Slaskich we Wroclawiu, Instytut Chorob Serca

Wroclaw, Basse-Silésie, Poland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

CAROLE MEILLEROUX, PharmD

CONTACT

+33622649277; carole.meilleroux@echosens.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: To minimize bias in clinical performance evaluation, the participant and operator of the device under test will be blinded to the clinical reference standard (ie, CVP as assessed by invasive hemodynamic catheter) result. The FibroScan operator will not be the same as the hemodynamic catheterization operator.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 30, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

PL (1); US (4); FR (1); DE (1)