NCT04001283

Nitrite Effects on Cardiac Muscle in CABG

Effect of Nitrite on Cardiac Muscle and Blood Vessels in Patients Undergoing Coronary Artery Bypass Grafting Surgery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of East Anglia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease
• Atherosclerosis
• Vascular Diseases
• Cardiac Disease
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sodium Nitrite	Intravenous drug infusion
DRUG	0.9% Sodium-chloride	Matched placebo

Timeline

• Start date: 2013-01-21
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2019-06-28
• Last updated: 2019-06-28

Locations

2 sites across 1 country: United Kingdom