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NOT YET RECRUITING
NCT07222813
NA

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

Sponsor: Echosens

View on ClinicalTrials.gov

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.

Official title: Performance of Liver Stiffness Measurement (LSM) by FibroScan® for the Diagnosis of Elevated Central Venous Pressure (CVP)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

149

Start Date

2026-01-15

Completion Date

2027-01-15

Last Updated

2025-10-30

Healthy Volunteers

No

Interventions

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

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