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

NCT06695429 | Recruiting

• 1 other identifier: RENACS
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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

  7 days

Secondary Outcomes (6)

• Number of Participants with In-hospital MACE (Major adverse cardiovascular events)

  Up to 30 days

• Number of Participants with In-hospital hyperkalemia

  Up to 30 days

• Rate of Drop-out from beetroot juice during hospitalization

  7 days

• Relative and absolute changes from baseline of serum creatinine and estimated glomerular filtration rate during follow-up

  1 year

• Number of Participants with Need for renal replacement therapy

  1 year

Study Arms (2)

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)

Dietary Supplement: Beetroot juice

Usual care

NO INTERVENTION

Usual treatment with hydration and statins to prevent contrast induced nephropathy

Interventions

Beetroot juice DIETARY_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.

Beetroot juice supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Hospital General Universitario Santa Lucia: lead

Study Sites (1)

Hospital Universitario Santa Lucía

Cartagena, Spain

RECRUITING

Central Study Contacts

Jose Manuel Andreu Cayuelas, PhD

CONTACT

+34 968 12 86 00; jmandreu@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: November 19, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: At request from other investigators, contacting with the contact-author. To perform meta-analyses or future studies about this matter.

Locations

ES (1)