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

ConditionFontan Circulation

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age8+

SponsorChildren's Mercy Hospital Kansas City

About this trial

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.

Eligibility criteria

Qualifiers

> 8 years

Status Post Fontan Completion

Ability to provide informed permission-assent (<18 years) or consent (≥18 years)

Fasting overnight (~8 hours)

Disqualifiers

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

Trial design

Treatments tested in this trial

Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg)
Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)

Treatment groups

15 Participants

are divided into 1 treatment group

Sponsors and collaborators

Children's Mercy Hospital Kansas City

Lead sponsor

Indiana Clinical and Translational Sciences Institute

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov