Nitrite Effects on Cardiac Muscle in CABG

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04001283
• Other study ID #: 87012
• Status: Recruiting
• Phase: Phase 2
• Start date: January 21, 2013
• Est. completion date: July 1, 2019

Study information

• Verified date: June 2019
• Source: University of East Anglia
• Contact: Nicholas D Gollop, MRCP(UK)
• Phone: 01603 591790
• Email: n.gollop[@]uea.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Males or females aged >18years scheduled to undergo coronary artery bypass grafting.

Exclusion Criteria:

Inability to read and understand the consent form and patient information leaflet Pregnancy and any woman of child bearing potential Patients with Type I diabetes Significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would affect subject safety and participation in the trial including severe heart failure (NYHAIII-IV and EF<40%) and severe renal impairment (requiring dialysis).

Unstable coronary syndrome (within 2 weeks) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency measured at screening in males of African, Asian or Mediterranean decent.

Receipt of an investigational drug or biological agent within the 4 weeks prior to study entry or 5 times the drug half-life, whichever is the longer.

Intended heart valve surgery or additional surgery or redo-CABG surgery.

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiac Disease
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Heart Diseases
• Myocardial Ischemia
• Vascular Diseases

Intervention

Drug:
• Sodium Nitrite
Intravenous drug infusion
• 0.9% Sodium-chloride
Matched placebo

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Papworth Hospital	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic 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	Taken during CABG surgery