CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Sildenafildrug
Likely dose
Sildenafil 40mgfrom 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/NCT01060020
NCT01060020Phase 4Completed
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Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

Washington University School of Medicine·interventional·Posted Feb 1, 2010·Updated Apr 25, 2018

In Brief

A Phase 4 clinical trial evaluating Sildenafil for Aortic Stenosis. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Pulmonary hypertension is common in patients with aortic stenosis and is associated with worse operative and long-term outcomes. Sildenafil has been shown to reduce pulmonary artery pressure and improve exercise performance in patients with left-sided heart failure, but this has not been tested in patients with aortic stenosis. We hypothesize that Sildenafil will produce a clinically significant decrease in pulmonary artery pressure in patients with severe aortic stenosis. The dose of Sildenafil that produces a significant decrease in pulmonary artery pressure will be safe and well tolerated in patients with and without a depressed ejection fraction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis
CountriesUnited States
CollaboratorsBarnes-Jewish Hospital

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2010
Enrollment StartJan 1, 2010
Primary CompletionSep 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.4 years ago

Interventions

Sildenafildrug

Single oral dose of 40mg or 80mg of Sildenafil