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Recruiting
NCT07222813
Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)
Conditions: Heart Failure, Heart Failure - NYHA II - IV
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 149
Sponsor: Echosens
Location: Keck Medicine of USC-Norris Healthcare Center - Transplant Clinic Los Angeles California
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 Criteria
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. Ascites
6. Heart transplantation
7. Pregnancy, breastfeeding, or intent to become pregnant during the study
8. Intent to donate/bank or retrieve eggs (ova, oocytes) or donate sperm during the study
Source: ClinicalTrials.gov (NCT07222813). StuddyBuddy aggregates publicly available trial information.