NITRATE-CIN Study: Protocol of a Randomized (1:1) Single-Center, UK, Double-Blind Placebo-Controlled Trial Testing the Effect of Inorganic Nitrate on Contrast-Induced Nephropathy in Patients Undergoing Coronary Angiography for Acute Coronary Syndromes

Beirne, Anne Marie, Mitchelmore, Oliver, Palma, Susana, Andiapen, Mervyn, Rathod, Krishnaraj S., Hammond, Victoria, Bellin, Anna, Cooper, Jackie, Wright, Paul, Antoniou, Sotiris, Yaqoob, Muhammad Magdi, Naci, Huseyin ORCID: 0000-0002-7192-5751, Mathur, Anthony, Ahluwalia, Amrita and Jones, Daniel A. (2021) NITRATE-CIN Study: Protocol of a Randomized (1:1) Single-Center, UK, Double-Blind Placebo-Controlled Trial Testing the Effect of Inorganic Nitrate on Contrast-Induced Nephropathy in Patients Undergoing Coronary Angiography for Acute Coronary Syndromes. Journal of Cardiovascular Pharmacology and Therapeutics, 26 (4). pp. 303-309. ISSN 1074-2484

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Abstract

Background: Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is a significant 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 novel effective treatments. Evidence suggests that delivery of nitric oxide (NO) through chemical reduction of inorganic nitrate to NO may offer a novel therapeutic strategy to reduce CIN and thus preserve long term renal function. Design: The NITRATE-CIN trial is a single-center, randomized, double-blind placebo-controlled trial, which plans to recruit 640 patients presenting with acute coronary syndromes (ACS) who are at risk of CIN. Patients will be randomized to either inorganic nitrate therapy (capsules containing 12 mmol KNO3) or placebo capsules containing potassium chloride (KCl) daily for 5 days. The primary endpoint is development of CIN using the Kidney Disease Improving Global Outcomes (KDIGO) criteria. A key secondary endpoint is renal function over a 3-month follow-up period. Additional secondary endpoints include serum renal biomarkers (e.g. neutrophil gelatinase-associated lipocalin) at 6 h, 48 h and 3 months following administration of contrast. Cost-effectiveness of inorganic nitrate therapy will also be evaluated. Summary: This study is designed to investigate the hypothesis that inorganic nitrate treatment decreases the rate of CIN as part of semi-emergent coronary angiography for ACS. Inorganic nitrate is a simple and easy to administer intervention that may prove useful in prevention of CIN in at-risk patients undergoing coronary angiographic procedures.

Item Type:	Article
Additional Information:	Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study is funded by Heart Research UK (HRUK) reference number RG2667 ( https://heartresearch.org.uk/a-new-treatment-to-prevent-kidney-damage-in-people-undergoing-angiography/ ). DJ is funded by The Barts Charity Cardiovascular Programme Award G00913, KSR by a National Institute for Health Research Academic Clinical Lectureship. Publisher Copyright: © The Author(s) 2021. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Divisions:	Health Policy
Date Deposited:	03 Jun 2021 10:12
Last Modified:	16 Nov 2024 04:12
URI:	http://eprints.lse.ac.uk/id/eprint/110758

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