Proteolytic Enzyme Induction Within the Human Myocardial Interstitium

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: Medical University of South Carolina
• Treatments: Sitaxsentan

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