Status:
RECRUITING
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
Lead Sponsor:
National Medical Research Center for Therapy and Preventive Medicine
Conditions:
Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06984406
Start Date
April 1 2025
End Date
March 1 2026
Last Update
May 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation
Moscow, Russia