Status:
NOT_YET_RECRUITING
Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)
Lead Sponsor:
Echosens
Collaborating Sponsors:
Syneos Health
Conditions:
Heart Failure
Heart Failure - NYHA II - IV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 assessment...
Detailed 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 filli...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Ascites
- Heart transplantation
- Pregnancy, breastfeeding, or intent to become pregnant during the study
- Intent to donate/bank or retrieve eggs (ova, oocytes) or donate sperm during the study
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT07222813
Start Date
January 15 2026
End Date
January 15 2027
Last Update
October 30 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Keck Medicine of USC-Norris Healthcare Center - Transplant Clinic
Los Angeles, California, United States, 90033
2
University of Minnesota
Minneota, Minnesota, United States, 55455
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
4
University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 Location
Dallas, Texas, United States, 75390