NCT03627130

The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 640 (actual)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Contrast-induced Nephropathy
• Acute Kidney Injury
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Potassium Nitrate	Potassium nitrate capsules (KNO3: 12 mmol giving 744 mg of nitrate) for 5 days
DRUG	Potassium Chloride	Potassium Chloride capsules for 5 days

Timeline

• Start date: 2018-11-29
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2018-08-13
• Last updated: 2022-12-16

Locations

1 site across 1 country: United Kingdom