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Studying Sildenafil and Pravastatin in Fontan-Associated Liver Disease

This study is looking at how the body processes two medications, sildenafil (often used for blood pressure in the lungs) and pravastatin (a cholesterol-lowering drug), in people with Fontan circulation. Fontan circulation is a special type of heart surgery. Researchers want to understand how liver issues, which can happen with Fontan circulation, affect how these drugs work. You might be able to join if you are over 8 years old, have had Fontan surgery, and can fast overnight. The study aims to measure the levels of sildenafil and pravastatin in your body over two years. The study is currently unclear on its recruitment status and plans to enroll 15 participants.

Study design
This is an open-label study, meaning you and the researchers will know which drugs are given. It is a single-center study, meaning it takes place at one location, and plans to enroll 15 participants.
What's involved
You would receive a single oral dose of sildenafil and a single oral dose of pravastatin. You would also need to fast overnight before participating.
Compensation
Not stated in the trial record.
Follow-up
The study will measure drug concentrations for two years after the single dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06324396

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

Recruiting
PHASE1Ages 8+InterventionalTreatment
Children's Mercy Hospital Kansas City
~15 participants
Updated 2026-01-02 on ClinicalTrials.gov
What's tested: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)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sildenafil concentration as measured by area under the curve (AUC)
Measured over 2 years
+1 more outcome measured

Conditions

Fontan Circulation

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Fontan Circulation

NCT06324396

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Mercy Hospital

    Kansas City, Missourino site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jonathan Wagner, DO · PRINCIPAL_INVESTIGATOR · Children's Mercy

Who to contact

Jonthan Wagner, DO
[email protected]
816-731-7240
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Sildenafil concentration as measured by area under the curve (AUC)2 years

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

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

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