Effect of Inorganic Nitrates (Beetroot Juice) on Arterial Hemodynamics and Exercise Capacity
Completed · Phase 2 · Has a placebo group
Conditions studied: Heart Failure With Normal Ejection Fraction
In brief
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.
Key facts
- Study ID
- NCT01919177
- Run by
- Corporal Michael J. Crescenz VA Medical Center
- People needed
- 17
- Starts
- 2013-01-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2015-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- In addition, subjects with heart failure must meet the following inclusion criteria:
- Chronic treatment with a loop diuretic for control of HF symptoms.
- 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.
- 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.
You may not qualify if…
- Rhythm other than sinus rhythm (i.e., atrial fibrillation).
- Neuromuscular, orthopedic or other non-cardiac condition that prevents patient from exercising.
- Valve disease (> mild aortic or mitral stenosis; > moderate aortic or mitral regurgitation).
- Hypertrophic cardiomyopathy.
- Known infiltrative or inflammatory myocardial disease (amyloid, sarcoid).
- Pericardial disease.
- Primary pulmonary arteriopathy.
- 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.
- 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.
- Systolic blood pressure < 110 mmHg or > 180 mm Hg.
- Diastolic blood pressure < 40 mmHg or > 100 mmHg.
- Resting heart rate (HR) > 100 bpm.
- Hemoglobin <10 g/dL.
- Patients with known severe liver disease (AST > 3x normal, alkaline phosphatase or bilirubin > 2x normal).
- Patients with a clinically indicated stress test demonstrating significant ischemia within a year of enrollment which was not followed by percutaneous or surgical revascularization.
- Current therapy with phosphodiesterase inhibitors, such as sildenafil, vardanafil or tadalafil.
- Known allergies to beetroot or lemon juice.
- Current use of organic nitrates or phosphodiesterase inhibitors.
- 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.
Where it is running
- Philadelphia Veterans Affairs Medical Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.