About this trial
The goal of this study is to compare the possible beneficial effect of beetroot juice supplementation versus the usual management during hospitalization to prevent contrast-induced nephropathy after cardiac catheterizations.
The study includes patients diagnosed with non-ST elevation acute coronary syndrome with a possible indication for catheterism and high risk of kidney injury related to iodinated contrast.
The intervention group will drink 500 mL (2 glasses daily, at breakfast and dinner) of beetroot juice added to the usual diet for 7 days or until hospital discharge and will receive the recommendation to maintain a diet rich in inorganic nitrates. The control group will receive the usual diet and recommendations. In both cases, other therapies will be prescribed to prevent contrast-induced nephropathy (hydration and statins) if there is no contraindication.
Our hypothesis is that a compound present in beetroot juice, inorganic nitrates, can prevent the deterioration of kidney function related to contrast due to its vasodilatory effect, in addition to improving the subsequent prognosis of coronary heart disease due to its anti-inflammatory and antiproliferative effects, protector of the endothelium and inhibitor of platelet aggregation. Beetroot juice could also be beneficial in this context due to the antioxidant effect of the betalains it contains.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Acute Coronary Syndrome without persistent ST segment elevation, with recommendation for invasive management according to the actual Clinical practice guidelines
At least moderate or high risk of nephropathy associated with iodinated contrast (Mehran score (without including contrast volume) ≥ 6).
Disqualifiers
<18 years old or without capacity to give consent.
Refusal to participate in the study.
Known hypersensitivity to beetroot or any of its allergens.
Pregnant.
Trial design
Parallel
Treatments tested in this trial
Beetroot juice
Dietary supplementSupplementation with 500 mL of beetroot juice daily in 2 doses of 250 mL, for 7 days, or until hospital discharge, and a recommendation to maintain a diet rich in vegetables with high nitrate content after discharge.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Contrast-induced nephropathy
Defined as an increase in serum creatinine ≥0.3 mg/dL in the first 48 hours or ≥1.5 times the baseline value during the week after the first PCI performed on admission
Secondary outcomes
Number of Participants with In-hospital MACE (Major adverse cardiovascular events)
Mortality from any cause, Myocardial infarction, PCI with unscheduled revascularization
Number of Participants with In-hospital hyperkalemia
K \>5.5 mEq/L (with previously normal values at admission)
Rate of Drop-out from beetroot juice during hospitalization
Abandonment of beetroot juice supplementation upon patient's request after having started it
Relative and absolute changes from baseline of serum creatinine and estimated glomerular filtration rate during follow-up
Change (Absolute and in porcentage from baseline) in serum creatinine (mg/mL) and glomerular filtration rate (estimated by CKD-EPI formula, in mL/min/1.73 m2) at 3-6 months and 9-12 months after PCI.
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