Chronic stable angina
Conditions
Interventions
Product Name: Inorganic Sodium Nitrate
Pharmaceutical Form: Capsule
INN or Proposed INN: Sodium Nitrate powder
CAS Number: 7631-99-4
Concentration unit: mmol millimole(s)
Concentration type: equal
Con
Sponsors
NHS Grampian, Aberdeen Royal Infirmary
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main outcome is to assess whether increasing plasma nitrate by dietary means increases the time to onset of angina using a Modified Bruce Exercise Test. ;Secondary Objective: The secondary outcome is to assess whether the heart functions better under stress using echocardiography, to assess whether angina frequency becomes less, whether the patient uses less GTN spray by means of an angina questionnaire.;Primary end point(s): The primary outcome is to assess whether increasing plasma nitrate by dietary means increases the time to onset of angina using a Modified Bruce Exercise Test.;Timepoint(s) of evaluation of this end point: All measurements will be done at baseline and after treatment. This should now be: All measurements will be done at visit 2 and 3. Other visits will include the following: Visit 1: Exercise test and Screening Dobutamine Stress Echocardiogram Visit 1B: Exercise test Visit 2: Exercist test, Dobutamine Stress Echo (if positive screening or clinical DSE), PET CT (in subgroup of 12 patients) and Seattle questionnaire Visit 3: Exercise test, Dobutamine Stress Echo (if positive screening or clinical DSE), PET CT (in subgroup of 12 patients) and Seattle questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are the global wall motion score at equivalent maximal dobutamine dose during dobutamine stress echocardiorgraphy, angina frequency, GTN use and a Seattle angina questionnaire. ;Timepoint(s) of evaluation of this end point: The secondary end points will be measured twice, once at baseline and again after treatment. This should now be: The secondary end points will be measured twice, once at visit 2 and once at visit 3. | — |
Countries
United Kingdom
Contacts
Public ContactHolland
Outcome results
None listed