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

Conditions

• Fontan Circulation

Eligibility Criteria

Sex

ALL

Age

8 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Mar 1, 2024

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Assessment Arm
  Assessment group will receive a single dose of oral sildenafil and oral pravastatin.

Primary Outcome Measure

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

Central Contacts

• Jonthan Wagner, DO
  816-731-7240
  [email protected]

Locations (1)

Find similar trials in Kansas City, MO

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