Efficacy and Safety of a Beet-Derived Inorganic Nitrate-Based Food Product for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Percutaneous Coronary Intervention

NCT06984406 | Recruiting DMC

• 1 other identifier: 02-02/25
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Contrast-induced nephropathy (CIN) is a common complication in high-risk patients undergoing percutaneous coronary intervention (PCI) due to exposure to iodinated contrast agents. CIN is associated with increased morbidity, prolonged hospital stays, and higher healthcare costs. Current preventive strategies include adequate hydration and minimizing contrast volume; however, there is no universally effective pharmacological intervention. Recent studies suggest that inorganic nitrates can enhance renal perfusion, reduce oxidative stress, and improve endothelial function, potentially lowering the risk of CIN. This study aims to evaluate the efficacy and safety of a beet-derived inorganic nitrate-based food product for the prevention of CIN in high-risk patients undergoing PCI. This is a randomized, controlled, open-label clinical trial comparing two groups:

1. 1.Intervention Group: Patients receiving the beet-derived inorganic nitrate-based food product for 5 days (starting 24 hours before PCI).
2. 2.Control Group: Patients receiving standard medical care without additional nitrate supplementation.
3. 3.A lower increase in kidney injury biomarkers (NGAL, cystatin C) in the intervention group.
4. 4.A slower decline or even improvement in eGFR at follow-up.
5. 5.A potential reduction in MACE due to the vasoprotective effects of nitrates.
6. 6.Improved quality of life scores (EQ-5D) in the intervention group. If successful, this study will provide new evidence supporting the use of dietary nitrates for renal protection and may contribute to the development of novel, cost-effective prevention strategies for CIN.

Conditions

Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)

Outcome Measures

Primary Outcomes (1)

• Incidence of Contrast-Induced Nephropathy (CIN)

  Contrast-induced nephropathy (CIN) will be defined based on KDIGO criteria as: * An increase in serum creatinine of ≥0.3 mg/dL (26.52 μmol/L) within 48 hours post-PCI, OR * An increase in serum creatinine of ≥1.5 times from baseline within 7 days post-PCI. * A urine output \< 0.5 mL/kg/hour for six hours. The incidence of CIN will be compared between the intervention (nitrate supplementation) and control groups.

  Baseline, 48 hours post-PCI

Secondary Outcomes (3)

• Changes in Renal Function Biomarkers (NGAL, Cystatin C, eGFR)

  Baseline, 4-6 hours, 24 hours, 48 hours, and 3 months post-PCI

• Incidence of Major Adverse Cardiovascular Events (MACE)

  3 months and 12 months post-PCI

• Quality of Life Assessment (EQ-5D Score)

  Baseline and 12 months post-PCI

Study Arms (2)

Nitrate Supplementation Group

EXPERIMENTAL

Participants in this arm will receive standard preventive measures for contrast-induced nephropathy, including adequate hydration and contrast volume minimization and in addition beet-derived inorganic nitrate-based food product as an oral supplement for 5 days. The intervention will start 24 hours before PCI and continue for 4 days post-procedure. The supplementation aims to enhance renal perfusion, reduce oxidative stress, and prevent contrast-induced nephropathy.

Dietary Supplement: Beet-Derived Inorganic Nitrate-Based Food Product

Standard Care Group

NO INTERVENTION

Participants in this arm will receive standard preventive measures for contrast-induced nephropathy, including adequate hydration and contrast volume minimization, but will not receive the nitrate-based supplement.

Interventions

Beet-Derived Inorganic Nitrate-Based Food Product DIETARY_SUPPLEMENT

This intervention consists of an orally administered food product enriched with inorganic nitrates derived from beetroot. Participants in the intervention group will consume a standardized dose of 12 mmol of nitrate per day for 5 days (starting 24 hours before PCI and continuing for 4 days post-procedure). The product is designed to enhance nitric oxide bioavailability, improve renal perfusion, reduce oxidative stress, and lower the risk of contrast-induced nephropathy (CIN).

Nitrate Supplementation Group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Planned PCI.
• High risk of CIN with:
• eGFR according to the CKD-EPI formula \<60 ml/min/1.73 m2 or
• At least two of the following criteria: liver damage (cirrhosis), diabetes mellitus, age \>70 years, administration of contrast in the last 7 days, CHF (LVEF \>40%), intake of drugs affecting renal function (ACE inhibitors, ARBs, NSAIDs, aminoglycosides, diuretics).
• Signing informed consent.

You may not qualify if:

• Allergy to nitrates.
• Acute coronary syndrome.
• Acute condition accompanied by systolic blood pressure \<90 mmHg for more th an 30 minutes or requiring the use of drugs with a positive inotropic effect.
• Life-threatening conditions requiring emergency medical care.
• Participation in other clinical trials.
• Pregnancy, lactation.
• Use of nitrates in the last 30 days.
• Abuse of alcohol, illegal drugs, mnestic-intellectual decline, as well as other reasons and circumstances indicating expected low adherence to treatment.
• Refusal to follow the plan of visits and examinations provided for by the protocol of this clinical trial.
• Refusal to sign informed consent.
• Infectious diseases.

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation

Moscow, Russia

RECRUITING

Central Study Contacts

Ann Levshina

CONTACT

+79158559968; levshina.ar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

RU (1)