NITRATE-CIN
Research type
Research Study
Full title
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
IRAS ID
232468
Contact name
Amrita Ahluwalia
Contact email
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Coronary angiography is a type of x-ray test which is used to look at the coronary arteries of the heart and help in the diagnosis of a number of heart conditions. It can also help in the planning of procedures such as balloon angioplasty and stent insertion to widen narrowed or blocked arteries in the heart.
During angiography, a special dye is injected which allows the blood vessels to show up on the x-ray. However, the dye can cause acute kidney injury called contrast induced nephropathy (CIN). In fact, CIN is the third most common cause of kidney failure that occurs in hospital. It is an important problem, as it is associated with a longer stay in hospital, higher healthcare costs, and a much worse outcome for patients with higher rates of complications and death.
There is evidence that contrast dye may cause kidney damage by reducing levels of nitric oxide (NO) in the kidneys. Dietary nitrate, which is abundant in vegetables such as beetroot, can increase the levels of NO in the body and this project will test whether taking nitrate in a capsule form can replace the lost NO in the kidneys and prevent CIN.
Patients will be divided into two groups; one group will take nitrate capsules and the other group ‘placebo’ or dummy capsules that do not contain nitrate. The researchers will then measure kidney function before the procedure, at two days and three months after, comparing the two groups to see if dietary nitrate makes a difference.
This study will show whether dietary nitrate capsules reduce kidney damage caused by coronary angiography. If successful, the benefits to patients with heart disease would be substantial with reduced rates of kidney damage, less need for treatments such as dialysis and better long term survival.
Summary: Coronary angiography is an x-ray test to look at the coronary arteries but a potential harmful complication is acute kidney damage. This project will test whether taking dietary nitrate capsules can reduce the risk of kidney damage following these procedures.
Lay Summary of Results
NITRATE-CIN recruited 640 patients who presented with a heart attack and were referred for invasive coronary angiography (ICA) and randomised them to either a 5 day treatment of dietary nitrate or placebo (sugar pill) before angiography. Improvement in the primary endpoint was seen with a significant reduction in contrast associated kidney damage seen. In addition 3 month kidney function was better and the risk of major cardiac events at one year (death, heart attack, further stenting procedures) were also lower in the nitrate treated group.
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT03627130%253Ftab%253Dresults%2FNBTI%2FBeS6AQ%2FAQ%2Ff6f19acf-46f8-448c-9a3c-1156b88d1d5c%2F2%2FojskgHIs0Y&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Cdc9538c64bc645df7e8d08dd3b9ae71b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638732258675699104%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=5JytwqfyVVFpfKQCybKbpYdPPq2AM5jW4yIDZbMBZa4%3D&reserved=0 - awaiting approval for release
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: Late Breaking Trial Presentation
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.escardio.org%252FThe-ESC%252FPress-Office%252FPress-releases%252FInorganic-nitrate-improves-safety-of-coronary-angiography-in-patients-at-renal-injury-risk%2FNBTI%2FBeS6AQ%2FAQ%2Ff6f19acf-46f8-448c-9a3c-1156b88d1d5c%2F3%2Fzl2ProArbi&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Cdc9538c64bc645df7e8d08dd3b9ae71b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638732258675716459%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=mrYWQU7eXAynFchKzl%2B7SgG95iuGtd3y7jLF7%2BpEXMg%3D&reserved=0Trial Publication
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Facademic.oup.com%252Feurheartj%252Farticle%252F45%252F18%252F1647%252F7633084%2FNBTI%2FBeS6AQ%2FAQ%2Ff6f19acf-46f8-448c-9a3c-1156b88d1d5c%2F4%2FgoW4IfR2PV&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Cdc9538c64bc645df7e8d08dd3b9ae71b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638732258675732913%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Lu2hGWFaW54K8t9LtWc73KTr4A9FQ6uESvBCwzzDSwA%3D&reserved=0
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: The trial was presented at a international conference with an open access publication making the results availablke. The results were shared in scientific and lay formats and widely disseminatedhttps://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.tctmd.com%252Fnews%252Fdietary-nitrate-dramatically-cuts-contrast-induced-nephropathy-nitrate-cin%2FNBTI%2FBeS6AQ%2FAQ%2Ff6f19acf-46f8-448c-9a3c-1156b88d1d5c%2F5%2FRdW3uUK3oM&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Cdc9538c64bc645df7e8d08dd3b9ae71b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638732258675749392%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=s%2BFVp233YGO3m%2BVWi22LFExmAmkbI4flR5yWgtw2BpM%3D&reserved=0
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.facebook.com%252Fsantanaheartsd%252Fposts%252F-inorganic-nitrate-benefits-contrast-induced-nephropathy-after-coronary-angiogra%252F400625252732519%252F%2FNBTI%2FBeS6AQ%2FAQ%2Ff6f19acf-46f8-448c-9a3c-1156b88d1d5c%2F6%2F2s1T3nwmBu&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Cdc9538c64bc645df7e8d08dd3b9ae71b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638732258675765484%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=wn9G2Dy9pUWMoUF5BR%2F11DIUROtED9Gqtky3eM%2FsYGM%3D&reserved=0
Interveiws were also posted onto public linked in accounts
Fianlly we have arranged an event for later this year for inteersted participants to attend to hear the results/answer any qs and be involved in fuiture study designb. Patients were asked at their 12 month f.u whether they wished to attend this or not/be contacted
If pending, date when feedback is expected: 01/04/2025
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: Data sharing available as advertsied in trial publication https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Facademic.oup.com%252Feurheartj%252Farticle%252F45%252F18%252F1647%252F7633084%2FNBTI%2FBeS6AQ%2FAQ%2Ff6f19acf-46f8-448c-9a3c-1156b88d1d5c%2F4%2FgoW4IfR2PV&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Cdc9538c64bc645df7e8d08dd3b9ae71b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638732258675780231%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=JaXmSjJtlH0cfjNiudUytO4myqoa9i4jJrzpxYS905o%3D&reserved=0
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: No tissue samples left for sharingREC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/1132
Date of REC Opinion
22 Aug 2018
REC opinion
Further Information Favourable Opinion