Performance of Liver Stiffness Measurement (LSM) by FibroScan® for the Diagnosis of Elevated Central Venous Pressure (CVP)
Echosens
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.
Description
CHF, as defined by the American College of Cardiology and the American Heart Association, is "a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood." These patients will often develop congestion that may require urgent hospitalization, especially if pulmonary congestion is present. However, congestion can be difficult to assess, especially when symptoms are mild, or in patients nearing discharge from an HF hospitalization.8 Increased cardiac filling pressures, including the CVP, often silently precede the appearance of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Have read, understood, and signed the informed consent form (ICF) 2. Be ≥18 years of age at the time of screening 3. Have suspected or diagnosed acute or chronic HF and be scheduled to undergo right-sided cardiac catheterization Exclusion Criteria: 1. Inability to consent 2. 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) 3. BMI \>40 kg/m2 4. Fontan-type circulation 5. Asc…
Interventions
- DeviceFibroScan
At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)
- ProcedureRight-sided Heart Catheterization
at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)
- ProcedureTransthoracic echocardiography
at Day 0 assessment of cardiac function
- BiologicalBlood 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 ClinicLos Angeles, California
- University of MinnesotaMinneota, Minnesota
- Medical University of South CarolinaCharleston, South Carolina
- University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 LocationDallas, Texas
- Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de PontchaillouRennes, Ile Et Vilaine
- Deutsches Herzzentrum der Charité (DHZC) - Klinik fuer Herz-, Thorax- und GefaesschirurgieBerlin