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RecruitingNCT06695429RENACSUpdated May 18, 2025

Supplementation With Beetroot Juice to Prevent Contrast Associated Nephropathy During Hospitalization for Acute Coronary Syndrome Without ST Elevation

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

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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:

  • Describe the effect of dietary supplementation with beetroot juice during hospital admission for NSTE ACS in the prevention of CIN after PCI.
  • Assess the tolerance of beetroot juice supplementation during admission by NSTE ACS and its possible relationship with adverse effects such as hyperkalemia.
  • Analyze the effect of the administration of beetroot juice during admission and recommendation upon discharge to maintain a diet rich in vegetables with a high content of nitrates on renal function during follow-up, including the need for initiation of renal replacement therapies.
  • Evaluate the relationship between the effect of the administration of beetroot juice during hospitalization and the recommendation upon discharge to maintain a diet rich in vegetables with high nitrate content with MACE during the first year of follow-up after NSTE ACS.

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:

  • Incidence of CIN during admission according to KDIGO creatinine criteria (increased Serum creatinine ≥0.3 mg/dL in the first 48 hours or ≥1.5 times the baseline value during the week after PCI)
  • Incidence of dropout due to juice intolerance in the intervention group, hyperkalemia (defined as K>5.5 mEq/L with previous normal values) or others adverse events during admission.
  • Evolution of glomerular filtration rate and need for renal replacement therapy during the first year after PCI.
  • Incidence of MACE and total mortality during the first year after PCI. Personal history, characteristics of NSTEA CS and PCI and creatinine values at admission, after PCI, during follow-up and treatments administered values will also be registered.
02

Conditions studied

  • Non ST Segment Elevation Acute Coronary Syndrome
  • Contrast Induced Nephropathy

Keywords

  • Beetroot juice
  • Inorganic nitrates
  • Contrast induced nephropathy
  • Non ST elevation acute coronary syndrome
  • Percutaneous coronary intervention
  • Contrast
03

In context

Kidney Diseases

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • \<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.
  • Inability to take food orally
  • Serious illnesses (not related to ACS or kidney failure), which limits their life expectancy to a period predictably less than 1 year.
  • On dialysis or predialysis at the time of inclusion.
  • ACS with persistent ST segment elevation before inclusion.
  • Shock or inotrope dependence at the time of inclusion
  • PCI already performed before inclusion.
  • Patients receiving intravenous nitroglycerin for > 1 hour before inclusion
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Beetroot juice supplementation

    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

  • No intervention
    Usual care

    Usual treatment with hydration and statins to prevent contrast induced nephropathy

Interventions

  • Dietary supplementBeetroot juice

    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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Number of Participants with In-hospital hyperkalemia

    K \>5.5 mEq/L (with previously normal values at admission)

    Time frame: Up to 30 days

  3. 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

  4. 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

  5. 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

  6. 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

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitario Santa Lucía
    Cartagena, Spain
    • Jose Manuel Andreu Cayuelas, PhD · Contact · jmandreu@msn.com · +34 968 12 86 00
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication

Supporting information: Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06695429
Lead sponsor
Hospital General Universitario Santa Lucia
Responsible party
Jose Manuel Andreu Cayuelas (Principal Investigator, Hospital General Universitario Santa Lucia) — Principal investigator
First posted
Nov 19, 2024
Start date
Oct 7, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
May 18, 2025

Study contacts

Jose Manuel Andreu Cayuelas, PhD
Contact
jmandreu@msn.com
+34 968 12 86 00

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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