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

Q

Queen's University

Status and phase

Completed
Phase 4

Conditions

Heart Failure, Systolic

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Nitrate supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT02401126
6012610

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

13 participants in 2 patient groups, including a placebo group

Nitrate supplementation
Active Comparator group
Description:
Concentrated nitrate-rich beetroot juice
Treatment:
Dietary Supplement: Nitrate supplementation
Placebo
Placebo Comparator group
Description:
Nitrate-depleted beetroot juice
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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