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.

A prospective, randomized, double‐blind, placebo‐controlled pilot study of sacubitril/valsartan (Entresto) in dogs with cardiomegaly secondary to myxomatous mitral valve disease

“…25 Lactose powder as a placebo control was packaged in a capsule and administered PO q12h. 30 The S/V and placebo in the capsule were similar in weight and visually indistinguishable. The dose of S/V was not adjusted during the study.…”

“…Sacubitril/valsartan (24/26, 49/51, and 97/103 mg tablets; Entresto, Novartis Pharmaceuticals, Basel, Switzerland) was enclosed in a gelatin‐coated capsule for the purpose of blinding and administered PO at a target dosage of 20 mg/kg q12h based on a previous study 25. Lactose powder as a placebo control was packaged in a capsule and administered PO q12h 30. The S/V and placebo in the capsule were similar in weight and visually indistinguishable.…”

Inorganic Nitrate in Angina Study: A Randomized Double‐Blind Placebo‐Controlled Trial

“…Secondary outcomes were time to chest pain onset, total exercise time, angina and GTN use frequency, modified Seattle Questionnaire, nitrate and nitrite plasma levels, angiogenic markers, and myocardial contractility assessment by peak systolic velocity measured by Doppler imaging (details described elsewhere) …”

“…After a 2‐week washout period the same procedure was repeated with bottle 2. Compliance with medication was assessed by patient via a checklist and by an investigator calculating the remaining capsules from return bottles . Patients were asked to follow a low‐nitrate and ‐nitrite diet, limit caffeine intake, and avoid use of antibacterial mouthwash .…”

“…In patients with minor resting ST depression (<1 mm), the time to 1‐mm ST change was defined as additional ST depression of 1 mm below the resting value . A 1‐mm ST depression was digitally detected and displayed by the CASE software at the J point (+80 milliseconds) …”