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

Официальное название

Randomized Controlled Trial on the 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 (BEET-CIN Trial)

Обзор

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.

Вмешательства

• Пищевая добавка 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).

Первичные конечные точки

• Incidence of Contrast-Induced Nephropathy (CIN) [Срок оценки: Baseline, 48 hours post-PCI]

Вторичные конечные точки (3)

• Changes in Renal Function Biomarkers (NGAL, Cystatin C, eGFR) [Срок оценки: Baseline, 4-6 hours, 24 hours, 48 hours, and 3 months post-PCI]
• Incidence of Major Adverse Cardiovascular Events (MACE) [Срок оценки: 3 months and 12 months post-PCI]
• Quality of Life Assessment (EQ-5D Score) [Срок оценки: Baseline and 12 months post-PCI]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Россия · 1 центр

• Federal State Budgetary Institution National Medical Research Center for Therapy and Preve — Moscow

Идентификаторы

NCT: NCT06984406 · 02-02/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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