The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

• Sponsor: University of Aberdeen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02078921
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Stable Angina	Drug: Sodium Nitrate; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Inorganic Nitrate on Cardiac Muscle: Physiology, Pharmacology and Therapeutic Potential in Patients Suffering From Angina
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Inorganic Nitrate	Drug: Sodium Nitrate
Placebo Comparator: placebo Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. 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

1. Onset of chest pain [12 weeks]

   Time to onset of chest pain on a modified Bruce protocol exercise test

2. Change in TDI systolic peak velocity [12 weeks]

   Change in Tissue Doppler Imaging (TDI) systolic peak velocity in ischaemic wall segments

3. Angina frequency [12 weeks]

   Angina frequency

4. GTN use frequency [12 weeks]

   GTN use frequency

5. Questionnaire Score [12 weeks]

   Modified Seattle Angina Questionnaire Score

6. Nitrate/Nitrite [12 weeks]

   Measurements of Nitrate and Nitrite in plasma

7. Metabolic, inflammatory and angiogenic plasma markers [12 weeks]

   Measurements of metabolic, inflammatory and angiogenic markers in plasma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Research facility, University of Aberdeen	Aberdeen		United Kingdom

Sponsors and Collaborators

• University of Aberdeen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aberdeen
• ClinicalTrials.gov Identifier: NCT02078921
• Other Study ID Numbers: 03/077/11
• First Posted: Mar 5, 2014
• Last Update Posted: Nov 5, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Angina Pectoris; Angina, Stable

Study Results

No Results Posted as of Nov 5, 2015