Improving drug dosing for patients with Fontan circulation and liver disease
Official title: IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
Run by Children's Mercy Hospital Kansas City · NCT06324396 · Data updated 2026-11-12
This study is testing how liver problems affect how kids and young adults with Fontan circulation process certain medications to find the best doses for them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 8 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | May 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT06324396 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children, adolescents, and young adults over 8 years old who have completed Fontan surgery and can provide informed consent or assent.
✕Probably not a fit
Patients who are pregnant, unable to fast, or have certain underlying health conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This investigation aims to understand how liver congestion and fibrosis affect drug metabolism in children, adolescents, and young adults who have undergone Fontan surgery. It is a single-center, open-label, prospective study that will quantify these effects by administering specific medications, including Sildenafil and Pravastatin, based on the patient's weight and age. The study will assess the pharmacokinetics of these drugs to optimize dosing and improve treatment outcomes for this unique patient population.
Why it matters
Potential benefit: If successful, this study could lead to more effective drug dosing strategies for patients with Fontan circulation, potentially improving their health outcomes.
How similar studies have gone: While this approach is novel in the context of Fontan-associated liver disease, similar studies in other populations have shown promise in optimizing drug dosing based on individual metabolic responses.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Children's Mercy Hospital
Kansas City, Missouri, United States Recruiting
Study contacts
- Principal investigator: Jonathan Wagner, DO — Children's Mercy
- Study coordinator: Jonthan Wagner, DO
- Email: jbwagner@cmh.edu
- Phone: 816-731-7240
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Venous Compression for Fontan Patients
This study tests whether wearing lower-extremity compression garments can increase exercise stroke volume in people with Fontan circulation.
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Dapagliflozin treatment for adults with failing Fontan circulation
This study is testing if dapagliflozin, a diabetes medication, can help adults with heart failure after the Fontan procedure feel better by looking at changes in their heart pressure during rest and exercise.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.