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

NCT ID: NCT03627130

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2022-05-30

Brief Summary

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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

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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

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Contrast-induced Nephropathy Acute Kidney Injury Acute Coronary Syndrome

Keywords

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Percutaneous Coronary Intervention Nitric Oxide Nitrite Acute Kidney Injury Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
IMP and placebo will be identical

Study Groups

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Potassium Nitrate

Potassium nitrate capsules (KNO3: 12 mmol giving 744 mg of nitrate) for 5 days

Group Type ACTIVE_COMPARATOR

Potassium Nitrate

Intervention Type DRUG

Potassium nitrate capsules (KNO3: 12 mmol giving 744 mg of nitrate) for 5 days

Potassium Chloride

Potassium Chloride

Group Type PLACEBO_COMPARATOR

Potassium Chloride

Intervention Type DRUG

Potassium Chloride capsules for 5 days

Interventions

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Potassium Nitrate

Potassium nitrate capsules (KNO3: 12 mmol giving 744 mg of nitrate) for 5 days

Intervention Type DRUG

Potassium Chloride

Potassium Chloride capsules for 5 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing coronary angiography+/-Percutaneous Coronary Intervention (PCI) for NSTE-ACS
2. Requirement for CIN prophylaxis as per Barts Heart Centre Criteria for CIN prophylaxis:

eGFR\<60ml/min OR 2 of the following: diabetes, liver failure (cirrhosis), age \> 70yr, exposure to contrast in last 7 days, heart failure (or LVEF\<40%), concomitant renally active drugs (ACEi, ARB, NSAIDs, aminoglycosides, diuretics)
3. Aged \>18
4. Patients able and willing to give their written informed consent.

Exclusion Criteria

1. ST segment myocardial infarction undergoing Primary PCI.
2. Patients with eGFR\<30ml/min or on renal replacement therapy
3. Subjects presenting with cardiogenic shock (systolic blood pressure \<80 mmHg for \>30 minutes, or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation
4. Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
5. Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication.
6. Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures).
7. Severe acute infection
8. Pregnancy
9. Breast-feeding mothers.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amrita Ahluwalia, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

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Barts Heart Centre

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Jones DA, Beirne AM, Kelham M, Wynne L, Andiapen M, Rathod KS, Parakaw T, Adams J, Learoyd A, Khan K, Godec T, Wright P, Antoniou S, Wragg A, Yaqoob M, Mathur A, Ahluwalia A. Inorganic nitrate benefits contrast-induced nephropathy after coronary angiography for acute coronary syndromes: the NITRATE-CIN trial. Eur Heart J. 2024 May 13;45(18):1647-1658. doi: 10.1093/eurheartj/ehae100.

Reference Type DERIVED
PMID: 38513060 (View on PubMed)

Beirne AM, Mitchelmore O, Palma S, Andiapen M, Rathod KS, Hammond V, Bellin A, Cooper J, Wright P, Antoniou S, Yaqoob MM, Naci H, Mathur A, Ahluwalia A, Jones DA. 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. J Cardiovasc Pharmacol Ther. 2021 Jul;26(4):303-309. doi: 10.1177/1074248421000520. Epub 2021 Mar 25.

Reference Type DERIVED
PMID: 33764198 (View on PubMed)

Other Identifiers

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18/1

Identifier Type: -

Identifier Source: org_study_id