NCT06324396View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Fontan Circulation
Interventions
DRUG

Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg)

A single oral dose of sildenafil will be administered to all study subjects.

DRUG

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

A single oral dose of pravastatin will be administered to all study subjects.

Trial Locations (1)

64108

RECRUITING

Children's Mercy Hospital, Kansas City

All Listed Sponsors
collaborator

Indiana Clinical and Translational Sciences Institute

OTHER

collaborator

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

NIH

lead

Children's Mercy Hospital Kansas City

OTHER