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

Echosens North America

Status: Not yet enrolling

Conditions: Heart Failure - NYHA II - IV; Heart Failure

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07222813

Cs002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 149 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

Full Cohort

Experimental group

Description:

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

Treatment:

Procedure: Transthoracic echocardiography

Biological: Blood Sample Analysis

Device: FibroScan

Procedure: Right-sided Heart Catheterization