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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: levshina.ar@gmail.com
• Phone: +79158559968

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using remote ischemic preconditioning to prevent kidney injury during coronary angiograms

  This study is testing if a simple treatment called remote ischemic preconditioning can help protect the kidneys from injury during coronary angiograms in patients who are at risk.

  Recruiting The University of Texas Medical Branch, Galveston · Galveston, Texas · NCT05147831

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.