- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Nicholas D Gollop, MRCP(UK)
- Phone Number: 01603 591790
- Email: n.gollop@uea.ac.uk
Study Locations
-
-
-
Cambridge, United Kingdom, CB2 0AY
- Recruiting
- Papworth Hospital
-
Contact:
- Nicholas D Gollop, MRCP(UK)
- Phone Number: 01603 591790
- Email: n.gollop@uea.ac.uk
-
Principal Investigator:
- Stephen Large, MD, FRCS
-
-
Scotland
-
Aberdeen, Scotland, United Kingdom, AB25 2ZN
- Completed
- Aberdeen Royal Infirmary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: sodium nitrite 24hours before
10umol/min intravenous sodium nitrite for 30minutes at 1ml/min over a period of 30minutes, 24 hours prior to CABG surgery
|
Intravenous drug infusion
|
EXPERIMENTAL: sodium nitrite 30minutes before
10umol/min intravenous sodium nitrite for 30minutes at 1ml/min over a period of 30minutes, 30 minutes prior to CABG surgery
|
Intravenous drug infusion
|
PLACEBO_COMPARATOR: 0.9% sodium chloride
Intravenous normal (0.9%) sodium chloride infused at 1ml/min
|
Matched placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic protein expression in cardiac biopsies and vascular offcuts
Time Frame: Taken during CABG surgery
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael P Frenneaux, MD, FRCP, Clinical Professor, Norwich Medical School, The University of East Anglia, UK
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 87012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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