Cholate Clearance in Fontan and Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHepQuant, LLC
About this trial
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.
Eligibility criteria
Qualifiers
Fontan: Adult Fontan patients ≥ 18 years of age who have undergone right heart catheterization within the past 1 year.
RHF Controls: non-Fontan adults with two ventricle anatomy with systemic left ventricle, CVP estimate ≥ 8 mmHg and left ventricle (LV) function ≥ 50% by echocardiogram performed within the past 1 year. Can include those with congenital heart disease- repaired or unrepaired.
Normal Controls: non-Fontan adults with normal cardiac anatomy, normal biventricular function, < moderate tricuspid regurgitation and CVP estimate < 5 mmHg by echocardiogram performed within the past 1 year.
Disqualifiers
Pregnant or breastfeeding
Unable to comprehend and/or give informed consent
Sensitivity to human serum albumin, or its preparations
Participants with extensive resection of large segments of the small intestine (short gut) or severe gastroparesis
Trial design
Treatments tested in this trial
- Dual cholate clearance assay
- MRI
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
HepQuant, LLC
Lead sponsor
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov