Recruiting
Phase 1

Drug Dosing

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT06324396

Conditions

Fontan Circulation

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

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)

Study Details

Brief summary:

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

Study ID

NCT06324396

Start date

Mar 1, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Assessment Arm

Assessment group will receive a single dose of oral sildenafil and oral pravastatin.

Interventions

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.

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.

Primary outcome measure

  • Sildenafil concentration as measured by area under the curve (AUC) [ Time Frame: 2 years ]
  • Pravastatin concentration as measured by area under the curve (AUC) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Jonthan Wagner, DO

816-731-7240jbwagner@cmh.edu

Locations

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Principal Investigator:

Jonathan Wagner, DO

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Jan 2, 2026

Last verified

Dec, 2025

Keywords

  • Fontan
  • FALD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-01-02.