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Completed

NCT Number: NCT02401126

Effects of Dietary Nitrate Supplementation on Cardiorespiratory Control in Chronic Heart Failure

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Nitrate supplementation

Dietary Supplement

Nitrate supplementation: concentrated nitrate-rich beetroot juice (2 x 70 ml/day; approximately 10 mmol nitrate/day; Beet It, James White Drinks, Ipswich, UK) for 8 consecutive days.

Other names: Concentrated nitrate-rich beetroot juice

Placebo

Dietary Supplement

Placebo: nitrate-depleted beetroot juice (2 x 70 ml/day; approximately 0.01 mmol nitrate/day; Beet It, James White Drinks, Ipswich, UK) for 8 consecutive days. The placebo juice is similar to the concentrated beetroot juice in appearance, texture, smell and taste and is obtained by removing nitrate ions from the latter.

Other names: Nitrate-depleted beetroot juice

Primary outcomes

  1. Exercise tolerance

    Time frame: 8 days

    Cycle ergometer exercise test to the limit of tolerance

Secondary outcomes

  1. Plasma nitrate and nitrite concentrations

    Time frame: 8 days

    Assessed by chemiluminescence

  2. Central and peripheral fatigue

    Time frame: 8 days

    Assessed by transcutaneous femoral nerve magnetic stimulation

  3. Skeletal muscle and cerebral blood flow and oxygenation

    Time frame: 8 days

    Assessed by near-infrared spectroscopy and the rate of appearance of the optically-dense indocyanine green dye

  4. Neuromuscular activity

    Time frame: 8 days

    Assessed by electromyography

  5. Dyspnea and leg effort scores

    Time frame: 8 days

    Evaluated via a 10-point Borg scale

  6. Cognitive performance

    Time frame: 8 days

    Assessed by computer-based tests

  7. Cardiorespiratory responses to exercise

    Time frame: 8 days

    Non-invasive evaluation of cardiac (mean arterial pressure, cardiac output, stroke volume and heart rate) and pulmonary gas exchange (e.g., minute ventilation and oxygen uptake) responses during the transition from rest to exercise

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 27, 2015
Registry last updated
May 2, 2016

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.

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