Overview

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

Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Barts & The London NHS Trust
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