At a glance
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Safety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle Patients
In Brief
A Phase 1 clinical trial evaluating Sildenafil by injection for Heart Disease. Completed, enrolled 21 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Sildenafil 0.125mg/kg injection over 20min
Sildenafil 0.25mg/kg injection over 20min
Sildenafil 0.35mg/kg by injection over 20min
Sildenafil 0.45mg/kg by injection over 20min