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Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)

Performance of Liver Stiffness Measurement (LSM) by FibroScan® for the Diagnosis of Elevated Central Venous Pressure (CVP)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether FibroScan, a test that measures liver stiffness without putting a tube into the body, can detect high pressure in the large veins near the heart. It is for adults with suspected or diagnosed heart failure who are scheduled for a test using a thin tube in the right side of the heart.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have read, understood, and signed the study consent form.
  • Be at least 18 years old at screening.
  • Have suspected or diagnosed heart failure, either recent or long-term, and be scheduled for a right-sided heart catheter test.

Who can't join

  • Cannot give consent to join the study.
  • Have long-term liver disease. Listed conditions include alcohol use over 14 drinks a week for females or 21 for males; positive hepatitis C or hepatitis B surface antigen tests; liver inflammation caused by the immune system; iron buildup; or blocked or slowed bile flow.
  • Have a body mass index (BMI), a measure of weight compared with height, over 40.
  • Have Fontan-type circulation, a surgically changed path for blood flow.
  • Have ascites, which is fluid buildup in the belly.
  • Have had a heart transplant.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Plan to donate, store, or have eggs collected, or donate sperm, during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (4)

CA

MN

SC

TX