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NCT07009132 · ClinicalTrials.gov registry record
Cholate Clearance in Fontan and Heart Failure
A clinical trial of Right Heart Failure and Fontan, sponsored by HepQuant.
- Recruiting
- Registry status
- 75
- Enrollment target
- 1
- Study location
NCT07009132: Recruiting study of Right Heart Failure and Fontan, sponsored by HepQuant.
NCT07009132 is a study of Right Heart Failure and Fontan that is actively recruiting participants, run by HepQuant. The registered enrollment target is 75 participants, below the 695-participant average among 4 other Right Heart Failure trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07009132, a study of Right Heart Failure and Fontan, is actively recruiting participants, sponsored by HepQuant.
- RECRUITING
- Registry status
- 75 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
13C-cholate and d4-cholate clearance as assessed by the dual cholate clearance test
Conditions Studied
Interventions
- RADIATION MRI
- DEVICE Dual cholate clearance assay
Study Locations (1)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2025-08-04 |
| Est. Completion | 2031-12 |
What NCT07009132 shows while recruiting
NCT07009132 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 695-participant average among 4 other Right Heart Failure trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Right Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which MRI is the first listed.
NCT07009132 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07009132 about?
NCT07009132 is a clinical study titled "Cholate Clearance in Fontan and Heart Failure". 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 l...
What is the current status of trial NCT07009132?
This trial is currently recruiting. The enrollment target is 75 participants. The study started on 2025-08-04. Estimated completion is 2031-12.
What conditions does trial NCT07009132 study?
This clinical trial studies the following conditions: Right Heart Failure, Fontan.
What interventions are being tested in trial NCT07009132?
The interventions under investigation include: MRI (RADIATION), Dual cholate clearance assay (DEVICE).
Who is sponsoring clinical trial NCT07009132?
This trial is sponsored by HepQuant, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07009132 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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