The Effects of Inorganic Nitrate on Cardiac Muscle: Physiology, Pharmacology and Therapeutic Potential in Patients Suffering From Angina
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time to 1mm ST depression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Treatment
Inorganic Nitrate
干预措施: Sodium Nitrate (Drug)
placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to 1mm ST depression
时间窗: 12 weeks
The primary outcome is to assess whether oral nitrate treatment increase the time to 1mm ST depression on a modified Bruce protocol exercise test
次要结局
- Change in TDI systolic peak velocity(12 weeks)
- Angina frequency(12 weeks)
- Questionnaire Score(12 weeks)
- Nitrate/Nitrite(12 weeks)
- GTN use frequency(12 weeks)
- Onset of chest pain(12 weeks)
- Metabolic, inflammatory and angiogenic plasma markers(12 weeks)