CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
1mg/kg sitaxsentan sodium +2 moredrug
Likely dose
1mg/kg sitaxsentan sodiumfrom 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/NCT00744211
NCT00744211N/ACompleted

Proteolytic Enzyme Induction Within the Human Myocardial Interstitium

VA Office of Research and Development·interventional·Posted Aug 29, 2008·Updated Nov 9, 2017

In Brief

A clinical study evaluating 1mg/kg sitaxsentan sodium, 2mg/kg sitaxsentan sodium, and 1 other intervention for Heart Disease. Completed, enrolled 29 participants across 1 site.

Detailed Summary

A robust release of endothelin-1-1 (ET) with subsequent ETA subtype receptor (ET-AR) activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass (CPB). Increased ET-AR activation has been identified in patients with poor left ventricular (LV) function (reduced ejection fraction; EF). Accordingly, this study tested the hypothesis that a selective ET-AR antagonist (ET-ARA) administered peri-operatively would favorably affect post-CPB hemodynamic profiles in patients with a pre-existing poor LVEF.

Study Details

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

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2008
Enrollment StartJul 1, 2008
Primary CompletionJun 1, 2011
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.8 years ago

Interventions

1mg/kg sitaxsentan sodiumdrug

1mg/kg sitaxsentan sodium (intravenous bolus) performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass.

2mg/kg sitaxsentan sodiumdrug

2mg/kg sitaxsentan sodium (intravenous bolus) performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass.

Vehicleother

Intravenous bolus performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass.