Results of a phase I/II multi-center investigation of udenafil in adolescents after fontan palliation.

ABSTRACT:

Background

The Fontan operation results in a circulation that is dependent on low pulmonary vascular resistance to maintain an adequate cardiac output. Medical therapies that lower pulmonary vascular resistance may augment cardiac output and improve long-term outcomes.

Objectives

This phase I/II clinical trial conducted by the Pediatric Heart Network was designed to evaluate short-term safety, pharmacokinetics (PK), and preliminary efficacy of udenafil in adolescents following Fontan.

Methods

A 5-day dose-escalation trial was conducted in five study cohorts of six subjects each (37.5, 87.5, and 125 mg daily, 37.5 and 87.5 mg by mouth twice daily). A control cohort with 6 subjects underwent exercise testing only. Adverse events (AEs) were recorded, PK samples were coll

SUBMITTER: Goldberg DJ 

PROVIDER: S-EPMC5458626 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature