NCT07222813

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (estimated)
• Sponsor: Echosens · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-12-31
• Completion: 2027-01-15
• First posted: 2025-10-30
• Last updated: 2025-10-30

Locations

7 sites across 4 countries: United States, France, Germany, Poland

Regulatory

• FDA-regulated device study