The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

Phase 2CompletedNCT02078921

University of Aberdeen70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Stable Angina

Interventions

Sodium NitrateDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Cardiovascular Research facility, University of Aberdeen

Aberdeen, United Kingdom

Outcomes

Primary Outcomes

Time to 1mm ST depression

The primary outcome is to assess whether oral nitrate treatment increase the time to 1mm ST depression on a modified Bruce protocol exercise test

Time frame: 12 weeks

Secondary Outcomes

Onset of chest pain

Time to onset of chest pain on a modified Bruce protocol exercise test

Time frame: 12 weeks

Change in TDI systolic peak velocity

Change in Tissue Doppler Imaging (TDI) systolic peak velocity in ischaemic wall segments

Time frame: 12 weeks

Angina frequency

Time frame: 12 weeks

GTN use frequency

Time frame: 12 weeks

Questionnaire Score

Modified Seattle Angina Questionnaire Score

Time frame: 12 weeks

Nitrate/Nitrite

Measurements of Nitrate and Nitrite in plasma

Time frame: 12 weeks

Metabolic, inflammatory and angiogenic plasma markers

Measurements of metabolic, inflammatory and angiogenic markers in plasma

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.