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NCT Number: NCT06324396

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

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.

Recruiting

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Key information

Conditions

Fontan Circulation

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location status: Recruiting

Location contact

Jonathan Wagner, DO

CONTACT

Jonathan Wagner, DO

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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 *History of solid organ transplantation

Treatment and study plan

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

Drug

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

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

Drug

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

Primary outcomes

  1. Sildenafil concentration as measured by area under the curve (AUC)

    Time frame: 2 years

    Area under the time-exposure curve (AUC 0-n) for sildenafil as determinants of the dose-exposure relationship.

  2. Pravastatin concentration as measured by area under the curve (AUC)

    Time frame: 2 years

    Area under the time-exposure curve (AUC 0-n) for pravastatin as determinants of the dose-exposure relationship.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonthan Wagner, DO

CONTACT

[email protected]

816-731-7240

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Indiana Clinical and Translational Sciences Institute

Registry information

Acronym: IMPROVE-FALD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2024
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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