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

Description

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

Fontan Circulation

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Fontan Circulation
Intervention / Treatment

-

Contacts and Locations

Kansas City

Children's Mercy Hospital, Kansas City, Missouri, United States, 64108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

8 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Mercy Hospital Kansas City,

Jonathan Wagner, DO, PRINCIPAL_INVESTIGATOR, Children's Mercy

Study Record Dates

2025-12-31