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COMPLETED
NCT00744211
NA

Proteolytic Enzyme Induction Within the Human Myocardial Interstitium

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2008-07

Completion Date

2013-04

Last Updated

2026-08-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

1mg/kg sitaxsentan sodium

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

DRUG

2mg/kg sitaxsentan sodium

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

OTHER

Vehicle

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

Locations (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States