An interventional study of Beet-Derived Inorganic Nitrate-Based Food Product in Contrast-induced Nephropathy Following Percutaneous Intervention (CIN), sponsored by National Medical Research Center for Therapy and Preventive Medicine. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by National Medical Research Center for Therapy and Preventive Medicine · Not applicable, Interventional, and Prevention
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:
We hypothesize that the nitrate-based food product will significantly reduce the incidence of CIN compared to standard care. Additionally, we expect:
National Medical Research Center for Therapy and Preventive Medicine is the lead sponsor of 29 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
High risk of CIN with:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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).
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
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
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National Medical Research Center for Therapy and Preventive Medicine