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The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

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ClinicalTrials.gov Identifier: NCT02078921
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Chronic Stable Angina Drug: Sodium Nitrate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

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



Primary Outcome Measures :
  1. Time to 1mm ST depression [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Time to onset of chest pain on a modified Bruce protocol exercise test

  2. Change in TDI systolic peak velocity [ Time Frame: 12 weeks ]
    Change in Tissue Doppler Imaging (TDI) systolic peak velocity in ischaemic wall segments

  3. Angina frequency [ Time Frame: 12 weeks ]
    Angina frequency

  4. GTN use frequency [ Time Frame: 12 weeks ]
    GTN use frequency

  5. Questionnaire Score [ Time Frame: 12 weeks ]
    Modified Seattle Angina Questionnaire Score

  6. Nitrate/Nitrite [ Time Frame: 12 weeks ]
    Measurements of Nitrate and Nitrite in plasma

  7. Metabolic, inflammatory and angiogenic plasma markers [ Time Frame: 12 weeks ]
    Measurements of metabolic, inflammatory and angiogenic markers in plasma



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078921


Locations
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United Kingdom
Cardiovascular Research facility, University of Aberdeen
Aberdeen, United Kingdom
Sponsors and Collaborators
University of Aberdeen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT02078921     History of Changes
Other Study ID Numbers: 03/077/11
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms