Effect of Dietary Nitrate Ingestion in Heart Failure (NCT03511248) | Clinical Trial Compass
TerminatedPhase 2
Effect of Dietary Nitrate Ingestion in Heart Failure
Stopped: abandoned
United Kingdom2 participantsStarted 2018-06-01
Plain-language summary
This study evaluates the addition of inorganic dietary nitrate to the optimal treatment of patients diagnosed with heart failure with reduced ejection fraction. Some vegetables contain large amounts of inorganic nitrate, and research suggests that this nitrate has beneficial effects on the heart and blood vessels. We have shown in lab experiments that nitrate has positive effects on the heart. We wish to test whether dietary nitrate might be useful in halting deterioration and/or improving heart function in patients with heart failure, with a specific focus on a marker of poor outcome in heart failure: high uric acid levels. Half of the patients will receive nitrate-rich beetroot juice, and the other half a nitrate-deplete placebo beetroot juice.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years
✓. Diagnosed with heart failure with reduced ejection fraction on the basis of:
✓. LVEF ≤50% as assessed by Echocardiography (or cardiac MRI)
✓. raised BNP and/or NT-proBNP levels placing patients in the "high risk" category, to ensure heart failure is the cause of symptoms:
✓. NYHA Class II-III symptoms
✓. On optimally-tolerated, stable (\>12 weeks) prognostic medical therapy (beta-blocker, ACE-inhibitor or ARB, mineralocorticoid therapy if deemed necessary)
✓. No heart failure-related hospitalisation for \>12 weeks
✓. Clinic systolic blood pressure ≥95mmHg
Exclusion criteria
✕. Use of anti-bacterial mouthwash or tongue scrapes (current or unwillingness to cease such mouthcare for at least one month prior to entering the study, and for the duration of the trial) as this interrupts the enterosalivary circuit and thus prevents the bioactivity of nitrate
✕. History of recurrent symptomatic gout or current treatment with xanthine oxidase inhibitors for hyperuricaemia
✕. Concomitant use of long acting organic nitrates or phosphodiesterase inhibitors (not including on an as required basis)
✕. Angina at CCS Class III/IV, requiring regular use of sublingual GTN (considered \>twice/week), or awaiting revascularisation
✕. If LVEF in the range 40-50%, impaires systolic function secondary to uncorrected valve disease, primary pulmonary hypertension, active myocarditis, constrictive pericarditis, restrictive cardiomyopathy or hypertrophic cardiomyopathy
✕. Renal failure with eGFR\<30 at screening
✕. History of symptomatic renal stone disease
✕. Current life-threatening condition that might prevent a patient-subject completing the study