The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

NCT02078921 | Completed Phase 2 DMC

• 1 other identifier: 03/077/11
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stable Angina

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (7)

• Onset of chest pain

  12 weeks

• Change in TDI systolic peak velocity

  12 weeks

• Angina frequency

  12 weeks

• GTN use frequency

  12 weeks

• Questionnaire Score

  12 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Inorganic Nitrate

Drug: Sodium Nitrate

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Sodium Nitrate DRUG

Treatment

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to do exercise test
• Women of child bearing potential
• 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)

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Cardiovascular Research facility, University of Aberdeen

Aberdeen, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28887315 DERIVED

• 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.

  PMID: 27730819 DERIVED

MeSH Terms

Conditions

Angina, Stable

Interventions

sodium nitrate

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: March 5, 2014
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 5, 2015

Record last verified: 2015-11

Locations

GB (1)