An interventional study of Beetroot juice in Non ST Segment Elevation Acute Coronary Syndrome and Contrast Induced Nephropathy, sponsored by Hospital General Universitario Santa Lucia. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Hospital General Universitario Santa Lucia · Not applicable, Interventional, and Prevention
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.
Contrast-induced nephropathy (CIN) is a common complication in patients admitted for acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI).
Although the deterioration of renal function is generally reversible, avoiding CIN is of great importance as it is associated with worse prognosis, including greater need for renal replacement therapies and greater mortality.
Inorganic nitrates (NO3-) are the most promising therapy to prevent CIN, due to their ability to be metabolized to nitric oxide (NO), whose vasodilator effect protects renal perfusion. In addition, NO has other potential benefits in ACS due to its anti-inflammatory, antiproliferative, endothelium protective, and platelet aggregation inhibitor effects.
The recent NITRATE-CIN study has shown that the administration of 12 mmol/24 h of KNO3 for 5 days to patients admitted for non-ST elevation (NSTE) ACS undergoing PCI not only significantly reduced the risk of CIN, but also prevented the deterioration of kidney function and significantly reduced major cardiovascular complications (MACE) during follow-up.
However, there is currently no comercially available presentation for KNO3 and its administration could be associated with hyperkalemia.
Furthermore, evidence of its use during admission for NSTE ACS comes from a single-center study with a small representation of Mediterranean population, which raises doubts about the validity of these results in our patients.
Drinking beetroot juice is a very promising alternative to administer NO3- during admission for NSTE ACS, due to its greater availability, simplicity of administration and minor risk of adverse effects such as hyperkalemia.
500 mL of beetroot juice daily contain approximately 11 mmol of NO3-, their consumption increases plasma NO similar to KNO3 and, in patients with chronic coronary syndrome, has been shown to reduce the risk of stent restenosis and MACE during follow-up, without significant adverse effects.
Objetives:
Study design:
PROBE study (Prospective Randomized Open, Blinded End-point) Nutritional intervention study. Unicentric. Study population: Patients >18 years old who enter our center with a diagnosis ofNSTE-ACS with indication for PCI and moderate or high risk of CIN (Mehran scale score not including contrast ≥ 6).
Intervention: Supplementation with 500 mL of beetroot juice daily in 2 doses of 250 mL, for 7 days or until discharge from admission for NSTE-ACS. Recommendation to maintain a diet rich in vegetables with high nitrate content after discharge.
The control group will follow the usual management and diet. In both groups, it will be administered treatment with hydration and statins to prevent CIN.
Analyzed Variables:
Relationship between supplementation with 500 mL of beetroot juice daily during admission for NSTE-ACS with:
3,838 studies on the registry are indexed under Kidney Diseases; 498 are open to participants now.
This study's planned enrollment of 130 is above the median of 70 across 2,639 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Hospital General Universitario Santa Lucia is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Supplementation 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. (In addition to usual treatment with hydration and statins to prevent contrast induced nephropathy)
Dietary Supplement: Beetroot juice
Usual treatment with hydration and statins to prevent contrast induced nephropathy
Supplementation 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.
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
Time frame: 7 days
Number of Participants with In-hospital MACE (Major adverse cardiovascular events)
Mortality from any cause, Myocardial infarction, PCI with unscheduled revascularization
Time frame: Up to 30 days
Number of Participants with In-hospital hyperkalemia
K \>5.5 mEq/L (with previously normal values at admission)
Time frame: Up to 30 days
Rate of Drop-out from beetroot juice during hospitalization
Abandonment of beetroot juice supplementation upon patient's request after having started it
Time frame: 7 days
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.
Time frame: 1 year
Number of Participants with Need for renal replacement therapy
Initiation of renal replacement therapy (Dialysis or Kidney transplant) during the follow-up.
Time frame: 1 year
Number of Participants with MACE during follow-up
Mortality from any cause, Myocardial infarction, PCI with unscheduled revascularization) during the first year after PCI
Time frame: 1 year
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Icf
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital General Universitario Santa Lucia