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
This trial accepts healthy volunteersQualifiers
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 population
Eligible Fontan participants will be identified by screening the Fontan database for patients who have undergone cardiac catheterization in the past year and by searching the outpatient clinic schedule. Eligible RHF and normal control participants will be screened through the outpatient echo lab schedule at Hospital of the University of Pennsylvania.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dual cholate clearance assay
DeviceStudy 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
RadiationUnsedated non contrast cardiac magnetic resonance imaging (MRI)
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Fontan2 interventions
Group B: Right Heart Failure (RHF) Controls2 interventions
Group C: Normal Controls2 interventions
Trial outcomes
Primary outcomes
1
Hepatic cholate clearance
13C-cholate and d4-cholate clearance as assessed by the dual cholate clearance test
Time frame
BaselineSecondary outcomes
1
Occurrence of at Least One Heart or Liver-Related Clinical Outcome
A patient will be considered to have a heart or liver-related clinical outcome if any of the following occur within 5 years after the first cholate assay: new-onset heart failure (defined as hospitalization for intravenous diuresis), progressive heart failure (defined as referral for heart or combined heart-liver transplant), clinically significant ascites (defined as requiring large volume paracentesis), new-onset protein-losing enteropathy, hepatocellular carcinoma, heart transplant or a combined heart and liver transplant, or death. Number of subjects with at least one of the above clinical outcomes will be captured and reported for all study groups.
Time frame
5 years after first cholate assaySponsors and contacts
Click on the lead sponsor to view all of their trials.
HepQuant, LLC
Lead sponsor
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov