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Statins

Drug Dosing for Liver Disease in Single Ventricle Patients (IMPROVE-FALD Trial)

Phase 1
Recruiting
Led By Jonathan Wagner, DO
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial will study how liver congestion and fibrosis affect how drugs are processed in the liver in young patients with Fontan circulation."

Who is the study for?
This trial is for children, adolescents, and young adults with a unique heart condition called Single Ventricle Heart and Fontan Circulation who also have liver disease. Specific eligibility details are not provided but typically include certain age ranges and health status requirements.
What is being tested?
The study is testing the effects of two medications, Sildenafil (in doses depending on weight) and Pravastatin (doses vary by age), on how the liver processes drugs in patients with Fontan circulation-related liver issues.
What are the potential side effects?
While specific side effects are not listed here, common ones for Sildenafil may include headaches, flushing, stomach discomfort; Pravastatin might cause muscle pain, digestive problems or changes in liver enzymes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pravastatin concentration as measured by area under the curve (AUC)
Sildenafil concentration as measured by area under the curve (AUC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Assessment ArmExperimental Treatment2 Interventions
Assessment group will receive a single dose of oral sildenafil and oral pravastatin.

Find a Location

Who is running the clinical trial?

Indiana Clinical and Translational Sciences InstituteOTHER
19 Previous Clinical Trials
4,408 Total Patients Enrolled
Children's Mercy Hospital Kansas CityLead Sponsor
257 Previous Clinical Trials
940,481 Total Patients Enrolled
Jonathan Wagner, DOPrincipal InvestigatorChildren's Mercy
~9 spots leftby Dec 2025
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