BridgeMD
New treatment option for Fontan Circulation
Official title IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
ClinicalTrials.gov ID: NCT06324396
What this study is testing
What is Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg)?
Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for fontan circulation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- \> 8 years
- Status Post Fontan Completion
- Ability to provide informed permission-assent (\<18 years) or consent (≥18 years)
- Fasting overnight (\~8 hours)
You likely can't join if
- 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...
- Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4/5) inducers/inhibitors) and/or Pravastatin (organic anion...
See the full 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 \ History of solid organ transplantation
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Missouri, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.