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

ConditionsHeart FailureHeart Failure - NYHA II - IV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEchosens

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • FibroScan

    Device

    At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)

  • Right-sided Heart Catheterization

    Procedure/Surgery

    at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)

  • Transthoracic echocardiography

    Procedure/Surgery

    at Day 0 assessment of cardiac function

  • Blood Sample Analysis

    Biological/Vaccine

    At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests

Treatment groups

149 Participants
are divided into 1 treatment group
Group A: Full CohortExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity]

Sensitivity (true positive rate) = TP / (TP + FN)

Time frame
at Day 0
2

Proportion of individuals without elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Specificity]

Specificity (1 - false negative rate) = TN / (TN + FP)

Time frame
at Day 0

Secondary outcomes

1

Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of elevated CVP (>10 mm Hg)

Time frame
at Day 0
2

Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of abnormal IVC diameter

Time frame
at Day 0
3

Logistic regression model to identify clinical, laboratory, and echocardiographic factors associated with LSM/CVP discordance.

Time frame
at Day 0
4

Correlation between LSM and echocardiographic parameters evaluated with Pearson or Spearman correlation coefficients

* Unit of measure: Pearson or Spearman coefficient * Measurement tool: linear regression

Time frame
at Day 0

Other outcomes

1

Number of patient presenting at least one adverse event

Time frame
7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Echosens

Lead sponsor

Syneos Health

Collaborator

Source ClinicalTrials.gov
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