Cholate Clearance in Fontan and Heart Failure

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Лучевая терапия MRI
  Unsedated non contrast cardiac magnetic resonance imaging (MRI)

Первичные конечные точки

• Hepatic cholate clearance [Срок оценки: Baseline]

Вторичные конечные точки (1)

• Occurrence of at Least One Heart or Liver-Related Clinical Outcome [Срок оценки: 5 years after first cholate assay]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Hospital of the University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07009132 · Fontan Cholate 2.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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