Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury

Inclusion Criteria:

• Planned coronary angiogram or contrast-enhanced CT scan.

• High-risk for contrast-associated acute kidney injury (AKI) with creatine/Glomerularfiltration rate (GFR) within 90 days as defined as:

1. Undergoing coronary angiogram with GFR <45 mL/min/1.73m2 OR

2. Undergoing coronary angiogram with GFR <60 mL/min/1.73m2 and concurrent risk ofAKI as defined by Hamilton et al. BMC2 risk prediction model ≥ 7%.OR

3. Undergoing contrast-enhanced CT scan with GFR<45 mL/min/1.73m2

• If subject is a woman of child-bearing potential, subject agrees to the use ofhighly effective contraception starting at screening and during study participation.

• Ability to take oral medication and be willing to adhere to the study interventionregimen.

• Ability to understand and willingness to agree to an informed consent

Exclusion Criteria:

• Already fulfilling definition of acute kidney injury prior to contrast exposure bykidney disease improving global outcomes (KDIGO) criteria (absolute increase increatinine from baseline of 0.3mg/dL or more OR relative increase in creatine of 50%or more from baseline).

• Primary indication for Percutaneous Coronary Intervention (PCI) including acuteST-segment elevation myocardial infarction

• End-stage renal disease actively on dialysis.

• Received any intravenous or intraarterial contrast within five days from plannedcontrast administration.

• Cardiac arrest within 14 days of planned contrast administration.

• Systolic blood pressure < 100mmHg or diastolic blood pressure <60mmHg OR currentlyreceiving inotropes or vasopressors for hemodynamic support.

• History of hypersensitivity or known allergy to any of the components of theinvestigational product or placebo including sodium nitrate, inorganic nitrate, beetroot juice, or lactose. This does not include lactose intolerance.

• Pregnancy or nursing female

• Participation in other investigational trials within the past 30 days prior toenrollment.

• Use of tadalafil within 48 hours, sildenafil or vardenafil within 24 hours, andavanafil within 12 hours of initiation of trial medication. If participant is oncontinuous dosing of tadalafil, sildenafil, vardenafil, or avanafil, they will beexcluded from the trial. If participant is on intermittent dosing of tadalafil,sildenafil, vardenafil, or avanafil, patient agrees to withhold use of medicationfor duration of medication treatment extending 48 hours after the final dose.