A randomized double-blind placebo-controlled crossover trial of sodium nitrate in patients with stable angina INAS

Abstract

In an aging western population, a significant number of patients continue to suffer from angina once all revascularization and optimal medical treatment options are exhausted. Under experimental conditions, oral supplementation with inorganic nitrate was shown to exhibit a blood pressure-lowering effect, and has also been shown to promote angiogenesis, improve endothelial dysfunction and mitochondrial efficiency in skeletal muscle. It is unknown whether similar changes occur in cardiac muscle. In the current study, we investigate whether oral sodium nitrate treatment will improve myocardial ischemia in patients with stable angina.

Trial registration: ClinicalTrials.gov NCT02078921.

Keywords: angina; inorganic nitrate; randomized controlled trial.

Conflict of interest statement

Financial & competing interests disclosure The study is funded by the Medical Research Council. Edura CT number: 2012-000196-17. Trial Registration: ClinicalTrials.gov NCT02078921. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

Figures

Figure 1.. Randomized double-blind placebo-controlled crossover design.

†Patient will be excluded if DSE or MPI positive, but they have recent angiographic evidence of non-obstructive coronary artery disease. DSE: Dobutamine stress echocardiogram; ETT: ECG treadmill test; MPI: Myocardial perfusion imaging; STD: ST segment depression.

Figure 2.. Proposed data analysis method.

(A) Example of ECG exercise treadmill test and time to 1 mm ST depression end point. (B) Dobutamine stress echocardiography, top – screening contrast dobutamine stress echocardiography (different stages of dobutamine stress, four-chamber view); bottom – example of native dobutamine stress echocardiography with tissue velocity imaging systolic velocity measurements, three-chamber view example). STD: ST segment depression.