The effects of inorganic sodium nitrate on cardiac and skeletal muscles.

• Conditions: Chronic stable angina; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-000196-17-GB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-21
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with chronic stable angina (>2 months duration) who are on no background antianginal therapy other than short acting nitrates will be recruited. Entry criteria comprise a positive exercise ECG (>2mm ST segment depression at the J2 point) at 3-9 mins on a modified Bruce protocol treadmill exercise test and a positive dobutamine stress echocardiogram.

This should now be:

Patients aged 18 and over with chronic stable angina (>=2 months duration). Patients can be on background anti-anginal therapy, however this dose of the background treatment has to ideally remain fixed during the trial. Entry criteria comprise a positive exercise ECG (>=1mm ST segment depression at the J point) within 9 mins on a modified Bruce protocol treadmill exercise test and either a positive dobutamine stress echocardiogram and/or a positive myocardial perfusion scan (MPI) and/or a positive coronary angiogram. Patients who meet these entry criteria but who have not had a 'clinical' dobutamine stress echocardiogram may also be asked to undergo a screening dobutamine stress echocardiogram (DSE). Those patients who have a positive DSE will be asked to have two further DSE's (one at the end of each limb of the study), which is a predefined secondary endpoint assessment.

This should now be:

Patients aged 18 and over with chronic stable angina (>=2 months duration). Patients can be on background anti-anginal therapy, however this dose of the background treatment has to ideally remain fixed during the trial. Entry criteria comprise a positive exercise ECG (>=1mm ST segment depression at the J point) on a modified Bruce protocol treadmill exercise test and either a positive dobutamine stress echocardiogram and/or a positive myocardial perfusion scan (MPI) and/or a positive coronary angiogram. Patients who meet these entry criteria but who have not had a 'clinical' dobutamine stress echocardiogram may also be asked to undergo a screening dobutamine stress echocardiogram (DSE). Those patients who have a positive DSE will be asked to have two further DSE's (one at the end of each limb of the study), which is a predefined secondary endpoint assessment.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients that are taking Calcium-channel blockers, Ivabradine, Nicorandil and long acting nitrates will be excluded. Women of child bearing age will be excluded from the study.

This should now be:
* Unable to do exercise test
* Women of child bearing potential
* If of a racial origin at risk of G6PD deficiency, G6PD will be excluded prior to inclusion in the study
* Resting STD>=1mm
* LBBB
* NYHA 3 or 4 HF or LVEF<45%
* Myocardial infarction or revascularisation within the last two months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified