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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Heart Failure - NYHA II - IV
• Interventions: Device: FibroScan; Procedure: Right-sided Heart Catheterization; Procedure: Transthoracic echocardiography; Biological: Blood Sample Analysis

• Registration Number: NCT07222813
• Lead Sponsor: Echosens

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).

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-17
• Study First Submitted QC: 2025-10-28
• Last Update Submitted: 2025-10-28
• Study First Posted: 2025-10-30
• Last Update Posted: 2025-10-30
• Study Start: 2026-01-15
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 149

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Full Cohort	FibroScan	This population will be defined by patients fulfilling all inclusion and exclusion criteria.
Full Cohort	Transthoracic echocardiography	This population will be defined by patients fulfilling all inclusion and exclusion criteria.
Full Cohort	Right-sided Heart Catheterization	This population will be defined by patients fulfilling all inclusion and exclusion criteria.
Full Cohort	Blood Sample Analysis	This population will be defined by patients fulfilling all inclusion and exclusion criteria.

Primary Outcome Measures

Name	Time	Method
Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity]	at Day 0	Sensitivity (true positive rate) = TP / (TP + FN)
Proportion of individuals without elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Specificity]	at Day 0	Specificity (1 - false negative rate) = TN / (TN + FP)

Secondary Outcome Measures

Name	Time	Method
Correlation between LSM and NT-proBNP evaluated with Pearson or Spearman correlation coefficients	at Day 0	* Unit of measure: Pearson or Spearman coefficient; * Measurement tool: linear regression
Logistic regression model to identify clinical, laboratory, and echocardiographic factors associated with LSM/CVP discordance.	at Day 0
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
Correlation between LSM and echocardiographic parameters evaluated with Pearson or Spearman correlation coefficients	at Day 0	* Unit of measure: Pearson or Spearman coefficient; * Measurement tool: linear regression
Correlation between LSM and CA-125 evaluated with Pearson or Spearman correlation coefficients	at Day 0	* Unit of measure: Pearson or Spearman coefficient; * Measurement tool: linear regression
Correlation between LSM and clinical parameters evaluated with Pearson or Spearman correlation coefficients	at Day 0	* Unit of measure: Pearson or Spearman coefficient; * Measurement tool: linear regression
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

Trial Locations

Locations (7)

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