Clinical trial NCT02078921: The Effects of Inorganic Nitrate on Cardiac Muscle in Angina
Official title: The Effects of Inorganic Nitrate on Cardiac Muscle: Physiology, Pharmacology and Therapeutic Potential in Patients Suffering From Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Stable Angina
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

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)

Primary outcomes:
measure: Time to 1mm ST depression
timeFrame: 12 weeks
Secondary outcomes:
measure: Onset of chest pain
timeFrame: 12 weeks
measure: Change in TDI systolic peak velocity
timeFrame: 12 weeks
measure: Angina frequency
timeFrame: 12 weeks
measure: GTN use frequency
timeFrame: 12 weeks
measure: Questionnaire Score
timeFrame: 12 weeks
measure: Nitrate/Nitrite
timeFrame: 12 weeks
measure: Metabolic, inflammatory and angiogenic plasma markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Cardiovascular Research facility, University of Aberdeen
Study officials:
References:
citation: 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.
citation: 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.