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New test could spot liver trouble early in fontan patients

NCT ID NCT07009132

Knowledge-focused Sponsor: HepQuant, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study is testing a new way to measure liver function in adults who have had the Fontan procedure, a surgery for certain heart defects. Researchers will use a dual cholate clearance test (a special blood test) and a heart MRI to see how well the liver is working. They will compare results from Fontan patients, people with right heart failure, and healthy volunteers, then follow everyone for 5 years to see if the test can predict future health problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a new, non-invasive way to monitor liver health in Fontan patients and predict future heart or liver problems.
What could go wrong
This is an early observational study, not a treatment trial. The test may not prove accurate or useful for predicting outcomes in this specific population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Participants on non-selective beta blockers, angiotensin converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), ursodeoxycholic acid, cholic acid, or other bile acids who are unwilling or unable to delay taking their normal dose the morning of their dual cholate clearance testing. * Participants on dietary supplements, bile acid sequestrants, GLP-1 agonists, narcotics, and other medications affecting gastric emptying or intestinal absorption who are unwilling or unable to delay taking or withhold as outlined in the instructions on deviating from the SHUNT test. * Contraindication to cardiac MRI * For RHF and normal controls: diabetes, chronic liver disease, \>moderate alcohol use, BMI \>30, oxygen-dependent, pulmonary hypertension22 on therapy, known porto-pulmonary hypertension

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Conditions

The condition(s) this trial relates to.

cor pulmonale Fontan-associated liver disease heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FONTAN Right heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.