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

Starting soon · Not applicable

Conditions studied: Heart Failure, Heart Failure - NYHA II - IV

In brief

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.

Key facts

Study ID

NCT07222813

Run by

Echosens

People needed

149

Starts

2026-01-15

Expected to finish

2027-01-15

Last updated by the study team

2025-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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