Expired Study
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Charleston, South Carolina 29401


Purpose:

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 summary:

Patients with a reduced LVEF were prospectively randomized, in a blinded fashion, at the time of elective coronary revascularization and/or valve replacement requiring CPB, to infusion of the highly-selective and potent ET-ARA, sitaxsentan at 1 or 2 mg/kg (IV bolus) or vehicle (saline). Infusion of the ET-ARA/vehicle was performed immediately prior to separation from CPB and again at 12 hrs post-CPB. ET and hemodynamic measurements were performed at baseline, at separation from CPB (Time 0) and at 0.5, 6, 12, 24 hrs post-CPB.


Criteria:

Inclusion Criteria: - >60 years of age - Body mass index <40 kg/m2 - Left ventricular ejection fraction less than or equal to 50% documented by a pre-operative echocardiogram - Patients undergoing coronary artery bypass (CABG), aortic and/or mitral valve replacement or combined CABG and valve procedures requiring CPB. - If diabetic, be under proper control, (fasting glucose <350 mg/dL or recent hemoglobin A1c [HgbA1c] <9%). - If hypertensive, be on a stable medical regimen with no significant changes over the past 30 days. - Female of child bearing potential with a negative pregnancy test, or post-menopausal for at least 2 years - The patient is an appropriate study candidate as determined by the Investigator on the basis of medical history and physical examination Exclusion Criteria: - Emergent revascularization - Previous stroke or thrombo-embolic event in the 3 months prior to study entry - A previous myocardial infarction within the last 7 days - Documented coagulopathy - Hepatic dysfunction as defined by aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times the upper limit of normal - Patient is pregnant or breastfeeding


NCT ID:

NCT00744211


Primary Contact:

Principal Investigator
Francis Spinale, MD PhD
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC


Backup Contact:

N/A


Location Contact:

Charleston, South Carolina 29401
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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