Clinical Trial: Sildenafil in Single Ventricle Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle Patients

Brief Summary:

Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the single ventricle palliation results in continued long term attrition. Elevated pulmonary vascular resistance and impaired systemic ventricular function are important risk factors for failure of single ventricle palliation.

Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in the pressure overloaded right ventricle.

The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of sildenafil in single ventricle patients following stage II and III surgical palliation.

Detailed Summary:
Sponsor: Duke University

Current Primary Outcome: Maximum Sildenafil Plasma Concentration [ Time Frame: 5 minutes after completion of sildenafil infusion ]

Original Primary Outcome: Sildenafil pharmacokinetics [ Time Frame: Within the first 24 hours after sildenafil adminstration ]

Current Secondary Outcome: Hemodynamic Safety and Efficacy [ Time Frame: 10 minutes after completion of sildenafil infusion ]

Original Secondary Outcome: Hemodynamic Safety and Efficacy [ Time Frame: 30 minutes after sildenafil administration ]

Information By: Duke University

Dates:
Date Received: July 7, 2010
Date Started: April 2011
Date Completion:
Last Updated: October 10, 2013
Last Verified: November 2012