The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

Chronic Stable Angina Clinical Trial

Official title:

The Effects of Inorganic Nitrate on Cardiac Muscle: Physiology, Pharmacology and Therapeutic Potential in Patients Suffering From Angina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078921
• Other study ID #: 03/077/11
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2014
• Last updated: November 4, 2015
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Chronic Stable Angina

Intervention

Drug:
• Sodium Nitrate

• Placebo

Locations

Country	Name	City	State
United Kingdom	Cardiovascular Research facility, University of Aberdeen	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Onset of chest pain	Time to onset of chest pain on a modified Bruce protocol exercise test	12 weeks	No
Secondary	Change in TDI systolic peak velocity	Change in Tissue Doppler Imaging (TDI) systolic peak velocity in ischaemic wall segments	12 weeks	No
Secondary	Angina frequency	Angina frequency	12 weeks	No
Secondary	GTN use frequency	GTN use frequency	12 weeks	No
Secondary	Questionnaire Score	Modified Seattle Angina Questionnaire Score	12 weeks	No
Secondary	Nitrate/Nitrite	Measurements of Nitrate and Nitrite in plasma	12 weeks	No
Secondary	Metabolic, inflammatory and angiogenic plasma markers	Measurements of metabolic, inflammatory and angiogenic markers in plasma	12 weeks	No