Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEchosens
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- FibroScan
- Right-sided Heart Catheterization
- Transthoracic echocardiography
- Blood Sample Analysis
Treatment groups
149 Participants
are divided into 1 treatment groupSponsors and collaborators
Echosens
Lead sponsor
Syneos Health
Collaborator
Source ClinicalTrials.gov