Effect of Inorganic Nitrates (Beetroot Juice) on Arterial Hemodynamics and Exercise Capacity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-11-30

Brief Summary

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The main objective is to test the hypothesis that inorganic nitrate supplementation will: (1) Improve exercise efficiency and performance; (2) Enhance the systemic vasodilator reserve during exercise and specifically, the vasodilator response in exercising muscle; (3) Reduce arterial wave reflections and arterial load; (4) Improve skeletal muscle mitochondrial function in subjects with heart failure with preserved ejection fraction.

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Detailed Description

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This represents a series of double-blind, controlled pilot randomized studies in which the effects of nitrate-rich beetroot juice and nitrate-depleted beetroot juice will be assessed in patients with heart failure and preserved ejection fraction (n=20). A total of 20 subjects will be enrolled over a 1.5 year period and randomized in a cross-over design to a single dose of nitrate-rich beetroot juice and nitrate-depleted beetroot juice. The order of the interventions will be randomized; thus, all subjects will receive the nitrate-rich and nitrate-depleted juice, with a 4-7 day washout period in-between studies.

Conditions

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Heart Failure With Normal Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nitrate rich beetroot juice

Subjects with heart failure with preserved ejection fraction will receive 140 mL of Nitrate-rich concentrated beetroot juice (containing 12 mmol of NO-3). This will be a cross-over study. Therefore all subjects will receive both interventions, but the order of the interventions will be randomized.

Group Type ACTIVE_COMPARATOR

Nitrate rich beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Subjects will receive 140 mL of Nitrate-rich concentrated beetroot juice.

Nitrate depleted beetroot juice

Subjects with heart failure with preserved ejection fraction will receive 140 mL of nitrate-depleted beetroot juice (containing \<0.01 mmol of NO-3).This will be a cross-over study. Therefore all subjects will receive both interventions, but the order of the interventions will be randomized.

Group Type PLACEBO_COMPARATOR

Nitrate depleted beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Subjects will receive 140 mL of nitrate-depleted beetroot juice.

Interventions

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Nitrate rich beetroot juice

Subjects will receive 140 mL of Nitrate-rich concentrated beetroot juice.

Intervention Type DIETARY_SUPPLEMENT

Nitrate depleted beetroot juice

Subjects will receive 140 mL of nitrate-depleted beetroot juice.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Beet It Stamina Sports shots Beet It nitrate extracted (depleted) placebo shots

Eligibility Criteria

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Inclusion Criteria

The investigators will enroll 20 subjects \>18 years of age who have a diagnosis of heart failure with preserved ejection fraction (\>50%) by 2d echocardiography, with current New York Heart Association Class II-IV symptoms.

1. Chronic treatment with a loop diuretic for control of HF symptoms.
2. If EF is normal, subjects must demonstrate elevated filling pressures as evidenced by at least one of the following: a) left atrial enlargement (LAVI \> 32 mL/m2); b) at least stage II diastolic dysfunction; c) Documentation of elevated NT-pro BNP levels or other natriuretic peptide marker (BNP, ANP) according to the laboratory and assay upper limit of normal in the previous year.
3. Stable medical therapy as defined by: (I) No addition or removal of ACE, ARB, beta-blockers, or calcium channel blockers (CCBs) for 30 days. (II) No change in dosage of ACE, ARBs, beta-blockers or CCBs of more than 100% for 30 days. (III) No change in diuretic dose for 10 days.

Exclusion Criteria

1. Rhythm other than sinus rhythm (i.e., atrial fibrillation).
2. Neuromuscular, orthopedic or other non-cardiac condition that prevents patient from exercising.
3. Valve disease (\> mild aortic or mitral stenosis; \> moderate aortic or mitral regurgitation).
4. Hypertrophic cardiomyopathy.
5. Known infiltrative or inflammatory myocardial disease (amyloid, sarcoid).
6. Pericardial disease.
7. Primary pulmonary arteriopathy.
8. Have experienced a myocardial infarction or unstable angina, or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to consent, or requires either PTCA or CABG at the time of consent.
9. Other clinically important causes of dyspnea such as morbid obesity or significant lung disease defined by clinical judgment or use of steroids or oxygen for lung disease within the past 6 months.
10. Systolic blood pressure \< 110 mmHg or \> 180 mm Hg.
11. Diastolic blood pressure \< 40 mmHg or \> 100 mmHg.
12. Resting heart rate (HR) \> 100 bpm.
13. Hemoglobin \<10 g/dL.
14. Patients with known severe liver disease (AST \> 3x normal, alkaline phosphatase or bilirubin \> 2x normal).
15. Patients with a clinically indicated stress test demonstrating significant ischemia within a year of enrollment which was not followed by percutaneous or surgical revascularization.
16. Current therapy with phosphodiesterase inhibitors, such as sildenafil, vardanafil or tadalafil.
17. Known allergies to beetroot or lemon juice.
18. Current use of organic nitrates or phosphodiesterase inhibitors.
19. Pregnancy. Although beetroot juice has not knows teratogenic effects, we feel that not enough data exist in this regard. Therefore, all females patients of reproductive age will be required to undergo a pregnancy test prior to enrollment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No