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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Inorganic Nitrate |
|
| placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Nitrate | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of chest pain | Time to onset of chest pain on a modified Bruce protocol exercise test | 12 weeks |
| Change in TDI systolic peak velocity | Change in Tissue Doppler Imaging (TDI) systolic peak velocity in ischaemic wall segments |
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Inclusion Criteria:
Inclusion Criteria Following screening visit:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Research facility, University of Aberdeen | Aberdeen | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28887315 | Derived | Schwarz K, Singh S, Parasuraman SK, Rudd A, Shepstone L, Feelisch M, Minnion M, Ahmad S, Madhani M, Horowitz J, Dawson DK, Frenneaux MP. Inorganic Nitrate in Angina Study: A Randomized Double-Blind Placebo-Controlled Trial. J Am Heart Assoc. 2017 Sep 8;6(9):e006478. doi: 10.1161/JAHA.117.006478. | |
| 27730819 | Derived |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C031618 | sodium nitrate |
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|
| 12 weeks |
| Angina frequency | Angina frequency | 12 weeks |
| GTN use frequency | GTN use frequency | 12 weeks |
| Questionnaire Score | Modified Seattle Angina Questionnaire Score | 12 weeks |
| Nitrate/Nitrite | Measurements of Nitrate and Nitrite in plasma | 12 weeks |
| Metabolic, inflammatory and angiogenic plasma markers | Measurements of metabolic, inflammatory and angiogenic markers in plasma | 12 weeks |
| Schwarz K, Singh S, Parasuraman SK, Bruce M, Shepstone L, Feelisch M, Minnion M, Ahmad S, Horowitz J, Dawson DK, Frenneaux MP. A randomized double-blind placebo-controlled crossover trial of sodium nitrate in patients with stable angina INAS. Future Cardiol. 2016 Nov;12(6):617-626. doi: 10.2217/fca-2016-0026. Epub 2016 Oct 12. |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |