CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Sildenafil by injection +3 moredrug
Likely dose
Sildenafil by injection 0.125mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01169519
NCT01169519Phase 1Completed

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

Duke University·interventional·Posted Jul 26, 2010·Updated Dec 5, 2013

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2010
Enrollment StartApr 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.9 years ago

Interventions

Sildenafil by injectiondrug

Sildenafil 0.125mg/kg injection over 20min

Sildenafil by injectiondrug

Sildenafil 0.25mg/kg injection over 20min

Sildenafil by injectiondrug

Sildenafil 0.35mg/kg by injection over 20min

Sildenafil by injectiondrug

Sildenafil 0.45mg/kg by injection over 20min