NCT01169519

Sildenafil in Single Ventricle Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 3 Months – 120 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DRUG	Sildenafil by injection	Sildenafil 0.125mg/kg injection over 20min
DRUG	Sildenafil by injection	Sildenafil 0.25mg/kg injection over 20min
DRUG	Sildenafil by injection	Sildenafil 0.35mg/kg by injection over 20min
DRUG	Sildenafil by injection	Sildenafil 0.45mg/kg by injection over 20min

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-07-26
• Last updated: 2013-12-05
• Results posted: 2013-12-05

Locations

1 site across 1 country: United States