The purpose of this study is to test whether sodium nitrite affects the expression of cellular proteins important for metabolic and vascular function in vascular offcuts and cardiac biopsies taken from patients undergoing coronary artery bypass grafting (CABG) surgery.
Nitrite has been shown in recent studies to improve cardiac performance, particularly in patients with heart failure. These improvements were demonstrated in measures that are independent of cardiac loading conditions, implying improved contractility via effects at a cellular level. In humans, coronary artery bypass graft (CABG) surgery presents an opportunity to safely obtain cardiac muscle biopsies and vascular tissue in order to investigate changes at a cellular level in these tissues. The aim of this study is to investigate whether sodium nitrite affects the expression of cellular proteins important for heart muscle metabolism and vascular function when infused prior to routine CABG surgery. Patients undergoing CABG surgery who provide written informed consent will receive intravenous sodium nitrite 24hours prior to surgery, 30 minutes prior to surgery, or placebo. As Type 2 Diabetes Mellitus is common in patients undergoing CABG surgery, and itself has profound effects on metabolism, these patients will be sub-grouped into a diabetic cohort for interpretation of the molecular biology results. The 24hours prior to surgery vs. placebo arm will take place first, followed by the 30minutes prior to surgery vs. placebo arm. The data from this study will provide important information on the effects of nitrite on heart muscle and blood vessel tissues, and inform larger clinical trials in patients with cardiovascular disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
75
Intravenous drug infusion
Matched placebo
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
COMPLETEDPapworth Hospital
Cambridge, United Kingdom
RECRUITINGMetabolic protein expression in cardiac biopsies and vascular offcuts
Cellular proteins that are important for metabolic regulation and vascular function that may be affected by nitrite such as eNOS, AKT, PDH
Time frame: Taken during CABG surgery
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