The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

Phase 2

Completed

• Conditions: Chronic Stable Angina
• Interventions: Drug: Placebo; Drug: Sodium Nitrate

• Registration Number: NCT02078921
• Lead Sponsor: University of Aberdeen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Placebo
Treatment	Sodium Nitrate	Inorganic Nitrate

Primary Outcome Measures

Name	Time	Method
Time to 1mm ST depression	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

Secondary Outcome Measures

Name	Time	Method
Change in TDI systolic peak velocity	12 weeks	Change in Tissue Doppler Imaging (TDI) systolic peak velocity in ischaemic wall segments
Angina frequency	12 weeks	Angina frequency
Questionnaire Score	12 weeks	Modified Seattle Angina Questionnaire Score
Nitrate/Nitrite	12 weeks	Measurements of Nitrate and Nitrite in plasma
GTN use frequency	12 weeks	GTN use frequency
Onset of chest pain	12 weeks	Time to onset of chest pain on a modified Bruce protocol exercise test
Metabolic, inflammatory and angiogenic plasma markers	12 weeks	Measurements of metabolic, inflammatory and angiogenic markers in plasma

Trial Locations

Locations (1)

Cardiovascular Research facility, University of Aberdeen; 🇬🇧 Aberdeen, United Kingdom