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The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

Primary Purpose

Chronic Stable Angina

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Sodium Nitrate
Placebo
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cardiovascular Research facility, University of Aberdeen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

placebo

Arm Description

Inorganic Nitrate

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2014
Last Updated
November 4, 2015
Sponsor
University of Aberdeen
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1. Study Identification

Unique Protocol Identification Number
NCT02078921
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Inorganic Nitrate
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Sodium Nitrate
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time to 1mm ST depression
Description
The primary outcome is to assess whether oral nitrate treatment increase the time to 1mm ST depression on a modified Bruce protocol exercise test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Onset of chest pain
Description
Time to onset of chest pain on a modified Bruce protocol exercise test
Time Frame
12 weeks
Title
Change in TDI systolic peak velocity
Description
Change in Tissue Doppler Imaging (TDI) systolic peak velocity in ischaemic wall segments
Time Frame
12 weeks
Title
Angina frequency
Description
Angina frequency
Time Frame
12 weeks
Title
GTN use frequency
Description
GTN use frequency
Time Frame
12 weeks
Title
Questionnaire Score
Description
Modified Seattle Angina Questionnaire Score
Time Frame
12 weeks
Title
Nitrate/Nitrite
Description
Measurements of Nitrate and Nitrite in plasma
Time Frame
12 weeks
Title
Metabolic, inflammatory and angiogenic plasma markers
Description
Measurements of metabolic, inflammatory and angiogenic markers in plasma
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Cardiovascular Research facility, University of Aberdeen
City
Aberdeen
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28887315
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.
Results Reference
derived
PubMed Identifier
27730819
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.
Results Reference
derived

Learn more about this trial

The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

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