Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)
Mezzion Pharma Co. Ltd
Summary
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.
Description
This study is a 26 week, prospective, multicenter, randomized, double-blinded, placebo-controlled safety and efficacy study of udenafil vs. placebo in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption (VO2 mL/kg/min) as measured by maximal cardiopulmonary exercise test (CPET) reading laboratory who will be blinded to treatment allocation.
Eligibility
- Age range
- 12–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment. 2. Participant consent or parental/guardian consent and participant assent. 3. Participant fluency in primary language of country in which study is being conducted. 4. Current antiplatelet or anticoagulant therapy. Exclusion Criteria: 1. Height \< 132 cm. 2. Weight \< 40 kg. 3. Hospitalization for acute decompensated heart failure within the last 12 months. 4. Current intravenous inotropic drugs. 5. Undergoing evaluation for heart transplantation or listed for transplantati…
Interventions
- DrugUdenafil
Active drug
- DrugPlacebo
Matching Placebo
Locations (40)
- Phoenix Children's HospitalPhoenix, Arizona
- Arkansas Children'sLittle Rock, Arkansas
- Children's Hospital of Los AngelesLos Angeles, California
- Rady Children's HospitalSan Diego, California
- UCSF Benioff Children's HospitalSan Francisco, California
- Children's Hospital of ColoradoDenver, Colorado