NCT07222813 · Echosens
Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)
What this study is about
This is a pivotal, global, forward-looking, 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.
View original scientific description
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.
Interventions
DEVICE
FibroScan
At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)
PROCEDURE
Right-sided Heart Catheterization
at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)
PROCEDURE
Transthoracic echocardiography
at Day 0 assessment of cardiac function
BIOLOGICAL
Blood Sample Analysis
At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests
Primary outcome measures
Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity]
Time frame: 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]
Time frame: at Day 0
Specificity (1 - false negative rate) = TN / (TN + FP)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- 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
Where
- Los Angeles, California
- Minneota, Minnesota
- Charleston, South Carolina
- Dallas, Texas
Collaborators
Syneos Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2026 · Source of record for eligibility and locations