The Nitrite and Coronary Flow Study

NCT04354051 | Completed Phase 1

• 1 other identifier: 228798
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pharmacodynamic proof of concept study investigating the physiological effects of systemic infusion of nitrite on coronary blood flow using MRI.

Conditions

Cardiovascular Diseases; Vasodilation; Hypoxia

Outcome Measures

Primary Outcomes (1)

• The effect of systemic sodium nitrite on the degree of vasorelaxation (captured by taking 4 sets of MRI images on the same study day, within a 2-hour window) in the coronary vessels in normoxia and hypoxia in healthy participants

  This will be measured on the study day through the acquisition of 4 set of separate MRI images (each image set acquisition duration 3-5 minutes). 4 conditions for image acquisition: normoxia without nitrite, hypoxia without nitrite, normoxia with nitrite and hypoxia with nitrite. Images captured using coronary MRI.

  All data and images collected on study day within a 2-hour time window. All study days are now complete.

Secondary Outcomes (1)

• The change in systemic levels of nitrate, nitrite and nitroso species after intravenous sodium nitrite infusion

  Anticipated within 1 year of study completion

Study Arms (1)

Sodium nitrite

EXPERIMENTAL

Drug: Sodium Nitrite

Interventions

Sodium Nitrite DRUG

Intravenous nitrite sodium infusion, dose 70μmol, of 5 minute duration (14μmol /min-1).

Sodium nitrite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged greater than or equal to 18 years
• Not known to have any significant past medical history and not having regular follow up
• Able to provide informed consent

You may not qualify if:

• Significant medical, surgical or psychiatric disease that in the opinion of the Clinical Research Fellow would affect subject safety or significantly impact his/her ability to comply with follow-up. This would include any known clotting disorders.
• Known allergy or intolerance to Nitrites
• Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency detected at screening in males of African, Asian or Mediterranean decent
• Female subjects must be of non-childbearing potential, defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH\>40mIU/ml or females who have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to enrolment
• 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
• Predisposed to acute on chronic limb ischemia evident from a history of claudication or known peripheral arterial disease
• Any contra-indication to MRI, including the presence of an implanted metal device or suspected metal foreign bodies

Sponsors & Collaborators

• University of East Anglia: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR4 7TJ, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Aneurysm; Hypoxia

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

Vascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrites; Nitrous Acid; Nitrogen Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael P Frenneaux, FRCP (UK)

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: April 21, 2020
• Study Start: July 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)