CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Sildenafil +1 moredrug
Likely dose
Sildenafil 20 mgfrom 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/NCT00507819
NCT00507819Phase 2Completed
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The Sildenafil After Fontan Operation Study

Children's Hospital of Philadelphia·interventional·Posted Jul 27, 2007·Updated May 5, 2015

In Brief

A Phase 2 clinical trial evaluating Sildenafil and Placebo for Hypoplastic Left Heart Syndrome and Tricuspid Atresia. Completed, enrolled 28 participants.

Detailed Summary

In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation. The investigators will also evaluate echocardiographic measures of ventricular function and measure quality of life changes using two validated quality of life measures. The hypothesis is that sildenafil will result in increased exercise tolerance in patients who have had the Fontan operation as compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoplastic Left Heart Syndrome, Tricuspid Atresia
Countries--
CollaboratorsThe Mark H. and Blanche M. Harrington Foundation

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 27, 2007
Enrollment StartDec 1, 2007
Primary CompletionApr 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.9 years ago

Interventions

Sildenafildrug

One 20 mg capsule of sildenafil will be taken by mouth three times-a-day.

Placebodrug

One placebo capsule will be taken by mouth three times-a-day.