The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

November 4, 2015 updated by: University of Aberdeen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom
        • Cardiovascular Research facility, University of Aberdeen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of chest pain
Time Frame: 12 weeks
Time to onset of chest pain on a modified Bruce protocol exercise test
12 weeks
Change in TDI systolic peak velocity
Time Frame: 12 weeks
Change in Tissue Doppler Imaging (TDI) systolic peak velocity in ischaemic wall segments
12 weeks
Angina frequency
Time Frame: 12 weeks
Angina frequency
12 weeks
GTN use frequency
Time Frame: 12 weeks
GTN use frequency
12 weeks
Questionnaire Score
Time Frame: 12 weeks
Modified Seattle Angina Questionnaire Score
12 weeks
Nitrate/Nitrite
Time Frame: 12 weeks
Measurements of Nitrate and Nitrite in plasma
12 weeks
Metabolic, inflammatory and angiogenic plasma markers
Time Frame: 12 weeks
Measurements of metabolic, inflammatory and angiogenic markers in plasma
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/077/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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