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

National Medical Research Center for Therapy and Preventive Medicine88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Interventions

Beet-Derived Inorganic Nitrate-Based Food ProductDIETARY_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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 48 hours post-PCI

Secondary Outcomes

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

Neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin C will be measured at baseline, 4-6 hours, 24 hours, and 48-72 hours post-PCI to assess early kidney injury. Estimated glomerular filtration rate (eGFR) will be calculated at baseline, 48-72 hours, and 3 months post-PCI to evaluate long-term renal function changes.

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

Incidence of Major Adverse Cardiovascular Events (MACE)

MACE will be defined as the composite of: Cardiovascular death Myocardial infarction Stroke Unplanned coronary revascularization The incidence will be compared between the two study arms.

Time frame: 3 months and 12 months post-PCI

Quality of Life Assessment (EQ-5D Score)

Changes in quality of life will be assessed using the EQ-5D questionnaire, a validated tool measuring five dimensions: Mobility Self-care Usual activities Pain/discomfort Anxiety/depression Scores will be compared between groups to evaluate the impact of nitrate supplementation.

Time frame: Baseline and 12 months post-PCI