Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00744211
Status:
COMPLETED
Last Update Posted:
2017-11-09
First Post:
2008-08-27
Brief Title:
Proteolytic Enzyme Induction Within the Human Myocardial Interstitium
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Proteolytic Enzyme Induction Within the Human Myocardial Interstitium
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Patients with a reduced LVEF were prospectively randomized in a blinded fashion at the time of elective coronary revascularization andor valve replacement requiring CPB to infusion of the highly-selective and potent ET-ARA sitaxsentan at 1 or 2 mgkg IV bolus or vehicle saline Infusion of the ET-ARAvehicle 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 05 6 12 24 hrs post-CPB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None