Effects of Dietary Nitrate Supplementation on Cardiorespiratory Control in Chronic Heart Failure
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|ClinicalTrials.gov Identifier: NCT02401126|
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : May 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Systolic||Dietary Supplement: Nitrate supplementation Dietary Supplement: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Dietary Nitrate Supplementation and Cardiorespiratory Control in Chronic Heart Failure: a Randomized, Placebo-controlled Trial|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Active Comparator: Nitrate supplementation
Concentrated nitrate-rich beetroot juice
Dietary Supplement: Nitrate supplementation
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 Name: Concentrated nitrate-rich beetroot juice
Placebo Comparator: Placebo
Nitrate-depleted beetroot juice
Dietary Supplement: Placebo
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 Name: Nitrate-depleted beetroot juice
- Exercise tolerance [ Time Frame: 8 days ]Cycle ergometer exercise test to the limit of tolerance
- Plasma nitrate and nitrite concentrations [ Time Frame: 8 days ]Assessed by chemiluminescence
- Central and peripheral fatigue [ Time Frame: 8 days ]Assessed by transcutaneous femoral nerve magnetic stimulation
- 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
- Neuromuscular activity [ Time Frame: 8 days ]Assessed by electromyography
- Dyspnea and leg effort scores [ Time Frame: 8 days ]Evaluated via a 10-point Borg scale
- Cognitive performance [ Time Frame: 8 days ]Assessed by computer-based tests
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401126
|Principal Investigator:||J. Alberto Neder, MD, PhD||Queen's University|