Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is an important cause of morbidity/mortality following coronary angiographic procedures in high-risk patients. Despite preventative measures intended to mitigate the risk of CIN, there remains a need for an effective intervention. Dietary inorganic nitrate therapy, which through its chemical reduction in the body delivers nitric oxide has shown promise in attenuating CIN, but its effectiveness in preserving long-term renal function is unknown.
The NITRATE-CIN trial is a single-centre, randomised double-blinded placebo-controlled trial, which plans to recruit, over a period of 2 years, 640 patients presenting with acute coronary syndromes (ACS) who are at risk of CIN. Patients will be randomised to either dietary inorganic nitrate therapy or placebo. The primary endpoint will be the development of CIN (KDIGO criteria). A key secondary endpoint will be whether nitrate therapy impacts upon persistent renal impairment over a 3-month follow-up period. Additional secondary endpoints include the measurement of serum renal biomarkers (e.g. neutrophil gelatinase-associated lipocalin) and urinary albumin at 6, 48 h and 3 months following administration of contrast. Findings from NITRATE-CIN will potentially demonstrate that nitrate attenuates contrast-induced acute and chronic kidney injury and influence future clinical practice guidelines in at-risk patients undergoing coronary angiographic procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
640
Potassium nitrate capsules (KNO3: 12 mmol giving 744 mg of nitrate) for 5 days
Potassium Chloride capsules for 5 days
Barts Heart Centre
London, United Kingdom
Contrast Induced Nephropathy
Defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Time frame: 48-72 hours
Demonstration of a persistent benefit of dietary inorganic nitrate against long-term renal impairment
Difference in real function as measured by eGFR (estimated glomerular filtration rate) at 3 months post-contrast exposure
Time frame: 3 months
Measurement of Circulating Nitrite and Nitrate levels
Plasma Nitrite/Nitrate levels
Time frame: Baseline, and at 6 hours, 48 hours and 3 months following treatment.
Major Adverse Cardiac Events
Defined as death, non-fatal myocardial infarction, revascularisation, acute heart failure, non-fatal stroke
Time frame: 3 and 12 months follow-up
Cost effectiveness of dietary inorganic Nitrate
Incremental Cost Effectiveness Ratio (ICER)
Time frame: 1 year
To determine if dietary inorganic nitrate ingestion decreases sub-clinical renal injury as measured by urinary renal biomarkers
Measurement of urinary IGFB7/TIMP-2
Time frame: 4-6 hours
To determine if dietary inorganic nitrate ingestion decreases sub-clinical renal injury as measured by serum biomarkers
Measurement of serum Neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: 4-6 hours
To determine if dietary inorganic nitrate decreases rates of post-procedural Myocardial Infarction
Definition as per Society for Cardiovascular Angiography and Interventions (SCAI)
Time frame: 6-12 hrs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.