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Cholate Clearance in Fontan and Heart Failure

NCT07009132 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2025-09-15

No results posted yet for this study

Summary

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.

Conditions

  • Fontan
  • Right Heart Failure

Interventions

DEVICE

Dual cholate clearance assay

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.

RADIATION

MRI

Unsedated non contrast cardiac magnetic resonance imaging (MRI)

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2026-12-31
Completion
2031-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07009132 on ClinicalTrials.gov