The Effect of Inorganic Nitrate on Contrast-Induced Nephropathy in Patients undergoing Coronary Angiography/Percutaneous Coronary Intervention for Acute Coronary Syndrome (ACS): A randomised single-centre, double-blind placebo-controlled trial.
Trial Objective: To determine whether an inorganic NO3- approach might prove useful adjunctive therapy improving renal function, reducing Contrast Induced Nephropathy (CIN) and improving outcomes in ACS patients undergoing angiography+/-PCI.
Disease area: Cardiovascular
Status: Actively recruiting
Chief Investigator: Professor Amrita Ahluwalia
Principal Investigator: Dr Dan Jones
Sponsor: Queen Mary University of London
NCT REF: ClinicalTrials.gov Identifier: NCT03627130
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. There is evidence that contrast dye may cause kidney damage by reducing levels of nitric oxide (NO) in the kidneys. 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 will test this approach in patients presenting with 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. 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.
Sample size and duration
640 patients aged 18 years or older presenting with acute coronary syndromes undergoing coronary angiography. The study will take place at Barts Heart Centre, London over a period of three years.
For further information, please contact:
Dr. Dan Jones
Tel: +44(0) 20 3765 8707
Anne-Marie Beirne (Sub-investigator)
Tel: +44(0) 20 3765 8706