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.
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
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome, Contrast Induced Nephropathy
- 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.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Santa Lucía
Cartagena
Jose Manuel Andreu Cayuelas, PhD, +34 968 12 86 00, jmandreu@msn.com
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 group | Role | What they receive |
|---|---|---|
| Beetroot juice supplementation | Experimental | 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) Receives: Dietary Supplement: Beetroot juice |
| Usual care | No intervention | Usual 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.
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)
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
Number of Participants with In-hospital hyperkalemia
K >5.5 mEq/L (with previously normal values at admission)
Measured: 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
Measured: 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.
Measured: 1 year
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
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.
- First posted19 Nov 2024
- Study start7 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST Segment Elevation Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Manuel Andreu Cayuelas, Hospital General Universitario Santa Lucia
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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06695429
- Acronym / sponsor ID
- RENACS / RENACS
- Keywords
- Beetroot juice, Inorganic nitrates, Contrast induced nephropathy, Non ST elevation acute coronary syndrome, Percutaneous coronary intervention, Contrast
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hospital General Universitario Santa LuciaUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice supplementation | Experimental | Dietary Supplement: Beetroot juiceSupplementation 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) |
| Usual care | No intervention | –Usual treatment with hydration and statins to prevent contrast induced nephropathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (11 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juiceSupplementation 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. | Dietary supplement | Beetroot juice supplementation |
Primary outcome
Number of Participants with Contrast-induced nephropathy
Time frame: 7 days
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
6 secondary outcomes
Number of Participants with In-hospital MACE (Major adverse cardiovascular events)
Time frame: Up to 30 days
Number of Participants with In-hospital hyperkalemia
Time frame: Up to 30 days
Rate of Drop-out from beetroot juice during hospitalization
Time frame: 7 days
Relative and absolute changes from baseline of serum creatinine and estimated glomerular filtration rate during follow-up
Time frame: 1 year
Number of Participants with Need for renal replacement therapy
Time frame: 1 year
Number of Participants with MACE during follow-up
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.