Chronic Stable AnginaPhase 2NCT02078921
The Effects of Inorganic Nitrate on Cardiac Muscle in Angina
A Phase 2 study testing Sodium Nitrate in people with Chronic Stable Angina, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Sodium Nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over with chronic stable angina (≥2 months duration).
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiovascular Research facility, University of Aberdeen
Aberdeen
About this study
Official title: 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.
- Conditions
- Chronic Stable Angina
- Being tested
- Sodium Nitrate, Placebo
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium NitrateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Inorganic Nitrate Receives: Drug: Sodium Nitrate |
| placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
Onset of chest pain
Time to onset of chest pain on a modified Bruce protocol exercise test
Measured: 12 weeks
Change in TDI systolic peak velocity
Change in Tissue Doppler Imaging (TDI) systolic peak velocity in ischaemic wall segments
Measured: 12 weeks
Angina frequency
Angina frequency
Measured: 12 weeks
GTN use frequency
GTN use frequency
Measured: 12 weeks
Questionnaire Score
Modified Seattle Angina Questionnaire Score
Measured: 12 weeks
Nitrate/Nitrite
Measurements of Nitrate and Nitrite in plasma
Measured: 12 weeks
Metabolic, inflammatory and angiogenic plasma markers
Measurements of metabolic, inflammatory and angiogenic markers in plasma
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078921
- Sponsor's protocol ID
- 03/077/11
- Status last verified
- Nov 2015
- First submitted
- 4 Feb 2014
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28887315Schwarz 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.
PubMed 27730819
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inorganic Nitrate on Cardiac Muscle: Physiology, Pharmacology and Therapeutic Potential in Patients Suffering From Angina
- ClinicalTrials.gov ID
- NCT02078921
- Acronym / sponsor ID
- 03/077/11
- Conditions
- Chronic Stable Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Sodium NitrateInorganic Nitrate |
| placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 and over with chronic stable angina (≥2 months duration).
- 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.
Key exclusion criteria (7 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Nitrate | Drug | Treatment |
| Placebo | Drug | placebo |
Primary outcome
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
7 secondary outcomes
Onset of chest pain
Time frame: 12 weeks
Change in TDI systolic peak velocity
Time frame: 12 weeks
Angina frequency
Time frame: 12 weeks
GTN use frequency
Time frame: 12 weeks
Questionnaire Score
Time frame: 12 weeks
Nitrate/Nitrite
Time frame: 12 weeks
Metabolic, inflammatory and angiogenic plasma markers
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Derived from this study: PubMed 28887315Schwarz 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.
- Derived from this study: PubMed 27730819Schwarz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Nitrate in people with Chronic Stable Angina, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to 1mm ST depression (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078921, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.