Skip to main content
OpenTrials
Completed

NCT Number: NCT02078921

The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cardiovascular Research facility, University of Aberdeen

Aberdeen, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sodium Nitrate

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2014
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.