Effect of dietary nitrate ingestion in stable angina

Not Applicable

Completed

• Conditions: Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular; Circulatory System

• Registration Number: ISRCTN72085021
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-21
• Study Completion: 2015-09-30
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Age between 18-80
2. Stable angina diagnosed on coronary angiography
3. Not taking any additional vitamin or food supplements
4. Long term use of antiplatelet agents such as aspirin, clopidogrel, or anticoagulants such as warfarin, plus a statin for a period of no less than one year
5. A previous history of known ischaemic heart disease, diabetes and stroke is acceptable as long as the subject’s condition is deemed stable at time of recruitment into the trial by the practitioner at time of screening

Exclusion Criteria

1. Patients already on organic nitrate treatment (Nicorandil, ISMN, GTN)
2. Previous history of myocardial infarction (MI) or systolic dysfunction
3. Previous coronary artery bypass surgery (CABG)
4. Current diagnosis of or treatment for malignancy, other than nonmelanoma skin cancer
5. Current life threatening condition other than vascular disease that may prevent a subject completing the study
6. Use of an investigational device or investigational drug within 30 days or 5 half lives (whichever is the longer) preceding the first dose of study medication
7. Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject’s unwillingness to comply with all study related procedures)
8. Severe acute infection, or significant trauma (burns, fractures)
9. Pregnancy. If there is any suggestion that a participant might be pregnant, a pregnancy test will be performed before recruitment
10. History of alcohol or drug abuse within the past 6 months
11. A history of heart failure NYHA class 24 or severe LV dysfunction LVEF<30% regardless of symptom status
12. Systemic autoimmune disease such as rheumatoid arthritis, connective tissue disease, or other conditions known to be associated with chronic inflammation such as inflammatory bowel disease
13. Subjects who have donated > 500mls blood within 56 days prior to study medication administration
14. Anaemia with Hb <10g/dl, or any other known blood disorder or significant illness that may affect platelet function, and coagulation. Known essential hypertension on antihypertensive medication is not a contraindication
15. Any non stable dosing of ongoing medication regimens throughout the study trial
16. A history of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody or other chronic hepatic disorder)
17. Abnormal liver function due to acute or chronic liver conditions 3 x upper limit of normal at screening
18. Renal impairment with creatinine clearance (eGFR) of <50ml/min at screening
19. BMI <18.5 or > or = 40kg/m2
20. Any patient requiring insulin (whether they are suffering from Type 1 or Type 2 diabetes mellitus)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of circulating nitrite levels over a 24h period