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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Transthoracic echocardiography: at Day 0 assessment of cardiac function

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (7)