Topic: Cardiovascular disease
Conditions
Interventions
Patients will be randomised to receive 4 mmol KNO3 or matched KCl capsules (placebo) with 250 ml of low nitrate containing water. This will occur at least 1 month and no more than 3 months prior to an
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 500mls blood within 56 days prior to study medication administration 14. Anaemia with Hb or = 40kg/m2 20. Any patient requiring insulin (whether they are suffering from Type 1 or Type 2 diabetes mellitus)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of circulating nitrite levels over a 24h period | — |
Countries
United Kingdom
Outcome results
None listed