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Clinical Trials/NCT02401126
NCT02401126
Completed
Phase 4

Dietary Nitrate Supplementation and Cardiorespiratory Control in Chronic Heart Failure: a Randomized, Placebo-controlled Trial

Queen's University0 sites13 target enrollmentMarch 2015

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Heart Failure, Systolic
Sponsor
Queen's University
Enrollment
13
Primary Endpoint
Exercise tolerance
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The main purpose of this study is to determine whether dietary nitrate supplementation via concentrated beetroot juice improves central and peripheral cardiovascular control and physical capacity in patients with systolic heart failure.

Detailed Description

Chronic heart failure (CHF) is a leading cause of morbidity and mortality worldwide. Although affecting the heart at first, it is now recognized that disability is largely due to impaired cerebral and skeletal muscle blood flow and consequently microvascular oxygenation. Reduced muscle oxygenation compromises oxidative metabolism and thus contractile performance. Impaired cerebral oxygenation not only reduces motor output (thus exacerbating muscle fatigue) but also constitutes a predictor of cerebral ischemic events and an independent prognostic risk factor. Reduced levels of the vasodilator nitric oxide (NO) contribute to impaired blood flow and oxygenation in CHF. Development of new effective therapeutic strategies is therefore crucial given that current pharmacological treatment has failed to abrogate oxygenation deficits in CHF patients. Emerging evidence shows that nitrate serves as an alternative source for NO and improves muscle blood flow and oxygenation in health. Another striking feature of nitrate is that it can improve muscle work efficiency, a tenet of physiology that was once considered immutable. Objective: To investigate systematically the role of dietary nitrate supplementation on central and peripheral cardiovascular function in CHF patients.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
April 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. J. Alberto Neder

Principal Investigator

Queen's University

Eligibility Criteria

Inclusion Criteria

  • previous diagnosis of systolic heart failure (left ventricular ejection fraction \<40%) under optimized clinical treatment as judged by the accompanying physician.

Exclusion Criteria

  • hospital admission in the previous 6 weeks;
  • exercise training program in the previous 6 months;
  • nitrate therapy (e.g., isosorbide dinitrate);
  • tabagism;
  • any condition that could interfere with the ability to exercise;
  • diagnosed psychiatric or cognitive disorders;
  • type I insulin-dependent diabetes mellitus;
  • excessively over-weight (BMI\>35kg/m²);
  • other diagnosed cardiorespiratory disorders (e.g., chronic obstructive pulmonary disease, peripheral artery disease).

Outcomes

Primary Outcomes

Exercise tolerance

Time Frame: 8 days

Cycle ergometer exercise test to the limit of tolerance

Secondary Outcomes

  • Plasma nitrate and nitrite concentrations(8 days)
  • Central and peripheral fatigue(8 days)
  • Skeletal muscle and cerebral blood flow and oxygenation(8 days)
  • Neuromuscular activity(8 days)
  • Dyspnea and leg effort scores(8 days)
  • Cognitive performance(8 days)
  • Cardiorespiratory responses to exercise(8 days)

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