Status:
COMPLETED
Proteolytic Enzyme Induction Within the Human Myocardial Interstitium
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Medical University of South Carolina
Conditions:
Heart Disease
Eligibility:
All Genders
60+ years
Phase:
NA
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 act...
Detailed Description
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-s...
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00744211
Start Date
July 1 2008
End Date
April 1 2013
Last Update
November 9 2017
Active Locations (1)
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1
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799