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

NCT ID: NCT07222813

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-01-15

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Full Cohort

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

Group Type: EXPERIMENTAL

FibroScan

Intervention Type: DEVICE

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

Right-sided Heart Catheterization

Intervention Type: PROCEDURE

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

Transthoracic echocardiography

Intervention Type: PROCEDURE

at Day 0 assessment of cardiac function

Blood Sample Analysis

Intervention Type: BIOLOGICAL

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

Interventions

FibroScan

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

Intervention Type: DEVICE

Right-sided Heart Catheterization

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

Intervention Type: PROCEDURE

Transthoracic echocardiography

at Day 0 assessment of cardiac function

Intervention Type: PROCEDURE

Blood Sample Analysis

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Echosens

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Keck Medicine of USC-Norris Healthcare Center - Transplant Clinic

Los Angeles, California, United States

University of Minnesota

Minneota, Minnesota, United States

Medical University of South Carolina

Charleston, South Carolina, United States

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

Dallas, Texas, United States

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

Rennes, Ile Et Vilaine, France

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

Berlin, , Germany

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

Wroclaw, Basse-Silésie, Poland

Countries

United States; France; Germany; Poland

Central Contacts

CAROLE MEILLEROUX, PharmD

Role: CONTACT

carole.meilleroux@echosens.com

+33622649277

Facility Contacts

Michael Fong, MD

Role: primary

michael.fong@usc.edu

Tamas Alexy, MD

Role: primary

alexy001@umn.edu

612-626-1240

Michele Esposito, MD

Role: primary

espositm@musc.edu

843-792-1105

Ambarish Pandey, MD, MSCS, FAHA

Role: primary

ambarish.pandey@utsouthwestern.edu

214-645-2101

Erwan Donal, MD

Role: primary

erwan.donal@chu-rennes.fr

33617708567

Felix Schoenrath, MD

Role: primary

felix.schoenrath@dhzc-charite.de

4.93046E+11

Jan Biegus, MD

Role: primary

janbiegus@gmail.com

48606674114

Other Identifiers

Cs002

Identifier Type: -

Identifier Source: org_study_id