Actively Recruiting
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
Led by Children's Mercy Hospital Kansas City · Updated on 2026-01-02
15
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
C
Children's Mercy Hospital Kansas City
Lead Sponsor
I
Indiana Clinical and Translational Sciences Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 8 years
- Status post Fontan completion
- Ability to provide informed permission-assent if under 18 years or consent if 18 years and older
- Fasting overnight for approximately 8 hours
You will not qualify if you...
- Pregnancy
- Not fasting
- Non-removable metal in body or any condition where MRI is unsafe
- Use of sildenafil and/or pravastatin therapy within the last 2 months
- History or laboratory evidence of intestinal, metabolic, autoimmune, or renal disease affecting drug disposition
- Use of medications that interact with sildenafil (CYP3A4/5 inducers/inhibitors) or pravastatin (OATP1B1 inducers/inhibitors)
- Inability to swallow tablets
- Liver enzyme levels (AST and ALT) or bilirubin levels greater than 5 times the age-specific upper limit of normal
- Diarrhea in the last 24 hours
- History of solid organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
Research Team
J
Jonthan Wagner, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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