The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

University of Aberdeen

Status and phase

Completed

Phase 2

Conditions

Chronic Stable Angina

Treatments

Drug: Placebo

Drug: Sodium Nitrate

Study type

Interventional

Funder types

Other

Identifiers

NCT02078921

03/077/11

Details and patient eligibility

About

Previous studies have shown that interventions which modestly increase blood nitrite_ improve skeletal muscle function on exercise while sparing oxygen, and have been also shown to open up the blood flow during periods of oxygen deprivation. Inorganic nitrate in the diet is absorbed into the bloodstream, concentrated and reduced by bacteria in the mouth to nitrite, which is then absorbed into the bloodstream. .

The purpose of this study is to look at the effects of oral inorganic nitrate supplementation on clinical markers of heart ischaemia and the frequency of angina.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged 18 and over with chronic stable angina (≥2 months duration).

Inclusion Criteria Following screening visit:

A positive exercise ECG (1mmSTD at J+0.08 seconds) on a modified Bruce protocol treadmill exercise test.
A positive dobutamine stress echocardiogram,
and/or a positive myocardial perfusion scan (MPI),
and/or a positive coronary angiogram.

Exclusion criteria

Unable to do exercise test
Women of child bearing potential
If of a racial origin at risk of glucose-6-phosphate dehydrogenase (G6PD) deficiency, G6PD will be excluded prior to inclusion in the study
Resting STD>=1mm
NYHA 3 or 4 HF or LVEF<45%
Myocardial infarction or revascularisation within the last two months
Left bundle branch block (LBBB)