Using a beet-based product to prevent kidney damage during heart procedures

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)

This study is testing if a beet-based product can help protect the kidneys from damage during heart procedures for patients who are at high risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Medical Research Center for Therapy and Preventive Medicine (Government)
• Locations: 1 site (Moscow)
• Trial ID: NCT06984406 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a beet-derived inorganic nitrate-based food product aimed at preventing contrast-induced nephropathy (CIN) in high-risk patients undergoing percutaneous coronary intervention (PCI). The study involves a randomized, controlled, open-label design, where participants will receive the product for five days starting 24 hours before the procedure. The trial seeks to determine if this intervention can enhance renal perfusion and reduce the risk of CIN compared to standard care. Current preventive strategies are limited, making this approach potentially significant for patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are scheduled for PCI and have a high risk of CIN due to specific medical conditions.

Not a fit: Patients with allergies to nitrates, acute coronary syndrome, or those requiring emergency medical care may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the incidence of contrast-induced nephropathy in high-risk patients, leading to better kidney health and reduced healthcare costs.

How similar studies have performed: While the use of inorganic nitrates for renal protection is a novel approach, recent studies suggest potential benefits, indicating that this area of research is promising but not yet fully established.

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.

Where this trial is running

Moscow

• Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation — Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: Ann Levshina

Conditions Contrast-induced Nephropathy Following Percutaneous Intervention