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

NCT ID: NCT06984406

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-03-31

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. Intervention Group: Patients receiving the beet-derived inorganic nitrate-based food product for 5 days (starting 24 hours before PCI).

2. Control Group: Patients receiving standard medical care without additional nitrate supplementation.

We hypothesize that the nitrate-based food product will significantly reduce the incidence of CIN compared to standard care. Additionally, we expect:

1. A lower increase in kidney injury biomarkers (NGAL, cystatin C) in the intervention group.

2. A slower decline or even improvement in eGFR at follow-up.

3. A potential reduction in MACE due to the vasoprotective effects of nitrates.

4. 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nitrate Supplementation Group

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.

Group Type: EXPERIMENTAL

Beet-Derived Inorganic Nitrate-Based Food Product

Intervention Type: 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).

Standard Care Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Beet-Derived Inorganic Nitrate-Based Food Product

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years.
• Planned PCI.
• High risk of CIN with:

1. eGFR according to the CKD-EPI formula <60 ml/min/1.73 m2 or

2. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Center for Therapy and Preventive Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Ann Levshina

Role: CONTACT

levshina.ar@gmail.com

+79158559968

Facility Contacts

Ann Levshina

Role: primary

levshina.ar@gmail.com

89158559968

Other Identifiers

02-02/25

Identifier Type: -

Identifier Source: org_study_id