Cholate clearance testing for adults with Fontan circulation or right-sided heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will perform the HepQuant dual cholate clearance assay and a cardiac MRI at baseline in three groups: adults with Fontan circulation, adults with right-sided heart failure (non-Fontan), and healthy controls. Results will be compared to determine how impaired hepatic blood flow relates to liver function in Fontan patients versus right heart failure and normal hearts. The study will track participants' health status and clinical outcomes for five years to see if cholate clearance predicts progression or complications. This is an observational protocol conducted at the Hospital of the University of Pennsylvania with standardized imaging and biochemical measurements.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital of the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.