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

Launched by NATIONAL MEDICAL RESEARCH CENTER FOR THERAPY AND PREVENTIVE MEDICINE · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a special food product made from beetroot, which contains inorganic nitrates, can help prevent a kidney problem called contrast-induced nephropathy (CIN) in patients who are at high risk and are scheduled for a heart procedure known as percutaneous coronary intervention (PCI). CIN can occur when patients are exposed to certain dyes during these procedures, leading to potential kidney damage. The trial will compare two groups: one group will receive this beet-derived product for five days before the procedure, while the other group will receive standard care without the product.

To participate, individuals must be at least 18 years old, planning to undergo PCI, and have a high risk of CIN, which may be indicated by certain health conditions like reduced kidney function or age over 70. Participants can expect to follow the study protocol, which includes taking the beet product before their procedure and undergoing follow-up assessments to see how their kidneys are doing. If successful, this study could lead to new ways to protect kidneys during heart procedures, helping improve patient outcomes and quality of life.

Gender

ALL

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.