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Cholate Clearance in Fontan and Heart Failure

Hepatic Perfusion and Liver Health as Assessed by Dual Cholate Clearance Assay in Fontan-associated Liver Disease (FALD)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether HepQuant, a test of how the liver clears cholate, can measure liver disease after Fontan heart surgery and predict future health. It compares adults who had Fontan surgery with adults who have right heart failure and healthy adults. Participants have the liver test and a heart MRI scan at the start, and their health is tracked for 5 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must qualify for one of these three adult groups.
  • Fontan group: Age 18 or older, with Fontan heart surgery and a right heart catheter test within the past year. This test uses a thin tube to check the heart.
  • Right heart failure group: No Fontan surgery; two lower heart chambers, with the left one pumping to the body. A heart ultrasound within the past year must show central vein pressure of at least 8 mmHg and left heart pumping function of at least 50%. Heart problems present at birth are allowed, whether repaired or not.
  • Healthy group: No Fontan surgery; normal heart shape and normal pumping in both lower chambers. A heart ultrasound within the past year must show less than moderate leaking of the tricuspid heart valve and central vein pressure below 5 mmHg.

Who can't join

  • Pregnant or breastfeeding.
  • Unable to understand the study or give informed consent.
  • Sensitive to human serum albumin, a blood protein, or products made with it.
  • Large parts of the small intestine removed, called short gut, or severely slowed stomach emptying.
  • Unable or unwilling to delay the morning dose of non-selective beta blockers, ACE inhibitors, ARBs, ursodeoxycholic acid, cholic acid, or other bile acids on the liver test day.
  • Unable or unwilling to pause supplements, bile acid sequestrants, GLP-1 medicines, narcotic pain medicines, or other drugs that affect stomach emptying or how the gut absorbs substances, as the test instructions require.
  • Unable to safely have a heart MRI scan.
  • For the right heart failure and healthy groups only: diabetes, long-term liver disease, more than moderate alcohol use, body mass index (BMI) above 30, needing oxygen, treated high blood pressure in the lungs, or known high lung blood pressure linked to high pressure in the liver’s blood vessels.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

PA