IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease

Recruiting now · Phase 1

Conditions studied: Fontan Circulation

In brief

This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.

Key facts

Study ID

NCT06324396

Run by

Children's Mercy Hospital Kansas City

People needed

15

Starts

2024-03-01

Expected to finish

2026-12-31

Last updated by the study team

2026-01-02

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 8 years
• Status Post Fontan Completion
• Ability to provide informed permission-assent (<18 years) or consent (≥18 years)
• Fasting overnight (\~8 hours)

You may not qualify if…

• Pregnancy
• Non-fasting
• Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe
• Sildenafil and/or Pravastatin therapy within last 2 months
• History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)
• Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4/5) inducers/inhibitors) and/or Pravastatin (organic anion transporting polypeptide (OATP1B1) inducers/inhibitors)
• Inability to swallow a tablet
• >5X the age-specific upper limit of normal for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total and conjugated bilirubin
• Diarrhea in the last 24 hours *History of solid organ transplantation

Where it is running

• Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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