The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Stable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Inorganic Nitrate

Group Type EXPERIMENTAL

Sodium Nitrate

Intervention Type DRUG

placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Sodium Nitrate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No