Can liver stiffness testing help detect high central venous pressure in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, cross-sectional study tests whether liver stiffness measurements by VCTE correlate with elevated central venous pressure in adults with suspected or diagnosed heart failure who are planned for right-sided heart catheterization. The study compares non-invasive liver elastography with invasive catheter data and standard echocardiography to explore a potential alternative for assessing congestion. It is global, prospective, and involves several sites to evaluate the feasibility and accuracy of this approach. The trial is sponsored by Echosens with collaborators and follows safety and consent procedures for adults. Data from this study could inform non-invasive strategies to manage heart failure congestion.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Minnesota
  Minneota, Minnesota, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 Location
  Dallas, Texas, United States Recruiting
• Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
  Rennes, Ile Et Vilaine, France Recruiting
• Deutsches Herzzentrum der Charité (DHZC) - Klinik fuer Herz-, Thorax- und Gefaesschirurgie
  Berlin, Germany Recruiting
• Uniwersytet Medyczny im. Piastow Slaskich we Wroclawiu, Instytut Chorob Serca
  Wroclaw, Basse-Silésie, Poland Recruiting

Study contacts

• Study coordinator: CAROLE MEILLEROUX, PharmD
• Email: carole.meilleroux@echosens.com
• Phone: +33622649277

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.