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Non ST Segment Elevation Acute Coronary SyndromeRENACSNCT06695429

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

A study testing Beetroot juice in people with Non ST Segment Elevation Acute Coronary Syndrome and Contrast Induced Nephropathy, run by Hospital General Universitario Santa Lucia at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Beetroot juice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteSpain
Study dates
7 Oct 2024to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • <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.
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jose Manuel Andreu Cayuelas, PhD contact

+34 968 12 86 00

jmandreu@msn.com

Spain1 site, 1 recruiting
  • Hospital Universitario Santa Lucía

    Cartagena

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

    Recruiting

Other trials in Spain

About this study

Official title: Suplementación Con Zumo de REmolacha Para Prevenir la Nefropatía Asociada a Contraste Durante la hospitalización Por Síndrome Coronario Agudo Sin elevación Del ST

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.

Read more

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.
Being tested
Beetroot juice
Keywords
Beetroot juice, Inorganic nitrates, Contrast induced nephropathy, Non ST elevation acute coronary syndrome, Percutaneous coronary intervention, Contrast

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beetroot juiceDietary supplement

    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.

Study groups in NCT06695429
Study groupRoleWhat they receive
Beetroot juice supplementationExperimentalSupplementation 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)
Receives: Dietary Supplement: Beetroot juice
Usual careNo interventionUsual treatment with hydration and statins to prevent contrast induced nephropathy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 days

Secondary outcomes (6)
  1. Number of Participants with In-hospital MACE (Major adverse cardiovascular events)

    Mortality from any cause, Myocardial infarction, PCI with unscheduled revascularization

    Measured: Up to 30 days

  2. Number of Participants with In-hospital hyperkalemia

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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start7 Oct 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06695429
Sponsor's protocol ID
RENACS
Acronym
RENACS
Status last verified
May 2025
First submitted
14 Oct 2024
Last updated
18 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A study testing Beetroot juice in people with Non ST Segment Elevation Acute Coronary Syndrome and Contrast Induced Nephropathy, run by Hospital General Universitario Santa Lucia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jose Manuel Andreu Cayuelas, PhD (+34 968 12 86 00, jmandreu@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Contrast-induced nephropathy (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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