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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Echosens
Study ID
NCT07222813
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FibroScan — DEVICE
    At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)
  • Right-sided Heart Catheterization — PROCEDURE
    at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)
  • Transthoracic echocardiography — PROCEDURE
    at Day 0 assessment of cardiac function
  • Blood Sample Analysis — BIOLOGICAL
    At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests

Study Details

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 Dates

First listed
Oct 30, 2025
Start date
Apr 23, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Jan 15, 2028

Study Design

Enrollment
149 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Full Cohort
    This population will be defined by patients fulfilling all inclusion and exclusion criteria.

Primary Outcome Measure

Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity] [ Time Frame: at Day 0 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Keck Medicine of USC-Norris Healthcare Center - Transplant ClinicLos AngelesCalifornia90033
Michael Fong, MD
[email protected]
University of MinnesotaMinneotaMinnesota55455
Tamas Alexy, MD
[email protected]
612-626-1240
Medical University of South CarolinaCharlestonSouth Carolina29425
Michele Esposito, MD
[email protected]
843-792-1105
University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 LocationDallasTexas75390
Ambarish Pandey, MD, MSCS, FAHA
[email protected]
214-645-2101

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Keck Medicine of USC-Norris Healthcare Center - Transplant Clinic· Los Angeles, CAUniversity of Minnesota· Minneota, MNMedical University of South Carolina· Charleston, SCUniversity of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 Location· Dallas, TX

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