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Search / Trial NCT03627130

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

Launched by BARTS & THE LONDON NHS TRUST · Aug 10, 2018

Trial Information

Current as of June 01, 2025

Completed

Keywords

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

ClinConnect Summary

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 (...

Gender

ALL

Eligibility criteria

  • 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.
  • 10. Any Inclusion Criteria not met

About Barts & The London Nhs Trust

Barts and The London NHS Trust is a leading healthcare organization in the United Kingdom, renowned for its commitment to delivering high-quality clinical care, research, and education. As a prominent sponsor of clinical trials, the Trust is dedicated to advancing medical knowledge and improving patient outcomes through innovative research initiatives. With a focus on patient safety and ethical standards, Barts and The London NHS Trust collaborates with multidisciplinary teams to explore cutting-edge therapies and interventions across various medical fields, ensuring that trial participants receive the highest level of care and support throughout their involvement.

Locations

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Amrita Ahluwalia, PhD

Principal Investigator

Queen Mary University of London

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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