NCT04001283

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_2 coronary-artery-disease

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2013

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

6.4 years

First QC Date

July 25, 2017

Last Update Submit

June 25, 2019

Conditions

Coronary Artery DiseaseAtherosclerosisVascular DiseasesCardiac DiseaseDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

sodium nitrite 24hours before

EXPERIMENTAL

10umol/min intravenous sodium nitrite for 30minutes at 1ml/min over a period of 30minutes, 24 hours prior to CABG surgery

Drug: Sodium Nitrite

sodium nitrite 30minutes before

EXPERIMENTAL

10umol/min intravenous sodium nitrite for 30minutes at 1ml/min over a period of 30minutes, 30 minutes prior to CABG surgery

Drug: Sodium Nitrite

0.9% sodium chloride

PLACEBO COMPARATOR

Intravenous normal (0.9%) sodium chloride infused at 1ml/min

Drug: 0.9% Sodium-chloride

Interventions

Sodium NitriteDRUG

Intravenous drug infusion

sodium nitrite 24hours beforesodium nitrite 30minutes before
0.9% Sodium-chlorideDRUG

Matched placebo

0.9% sodium chloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

COMPLETED

Papworth Hospital

Cambridge, CB2 0AY, United Kingdom

RECRUITING

Related Publications (1)

  • Ntessalen M, Procter NEK, Schwarz K, Loudon BL, Minnion M, Fernandez BO, Vassiliou VS, Vauzour D, Madhani M, Constantin-Teodosiu D, Horowitz JD, Feelisch M, Dawson D, Crichton PG, Frenneaux MP. Inorganic nitrate and nitrite supplementation fails to improve skeletal muscle mitochondrial efficiency in mice and humans. Am J Clin Nutr. 2020 Jan 1;111(1):79-89. doi: 10.1093/ajcn/nqz245.

    PMID: 31599928DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosisVascular DiseasesHeart DiseasesDiabetes Mellitus

Interventions

Sodium NitriteSodium Chloride

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitritesNitrous AcidNitrogen CompoundsInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Michael P Frenneaux, MD, FRCP

    Clinical Professor, Norwich Medical School, The University of East Anglia, UK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas D Gollop, MRCP(UK)

CONTACT

01603 591790n.gollop@uea.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

June 28, 2019

Study Start

January 21, 2013

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

June 28, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)