Cholate Clearance in Fontan and Heart Failure

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
HepQuant, LLC
Study ID
NCT07009132
Status
Recruiting
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Conditions

  • Fontan
  • Right Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dual cholate clearance assay — DEVICE
    Study participants are administered labeled oral and intravenous cholate, and then two blood samples are taken over 60-minutes. Serum cholate levels are measured by blood draws.
  • MRI — RADIATION
    Unsedated non contrast cardiac magnetic resonance imaging (MRI)

Study Details

The goal of this study is to use the HepQuant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of Fontan-associated liver disease (FALD). This study aims to understand the role impaired blood flow to the liver plays in liver function in Fontan patients compared to patients with right heart failure and healthy controls. The study will also determine whether cholate clearance is a good measure to use in this population, and whether it will be able to predict clinical outcomes. Participants will undergo a HepQuant dual cholate clearance assay and a cardiac magnetic resonance imaging (MRI) at the beginning of the study, and then data on health status will be collected for 5 years.

Key Dates

Start date
Aug 4, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2031

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: Fontan
    Patients with a Fontan diagnosis who have undergone a right heart catheterization in the past year
  • Arm: Right Heart Failure (RHF) Controls
    Non-Fontan patients with RHF (patients with normal 2-ventricle anatomy who have intermediate or elevated right-sided filling pressures (CVP) by echocardiogram)
  • Arm: Normal Controls
    Patients with normal cardiac anatomy and normal CVP (right-sided filling pressure) by echocardiogram.

Primary Outcome Measure

Hepatic cholate clearance [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Bella Clinical Research Coordinator
[email protected]
215-615-3388
Yuli Kim, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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