Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07016074

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

Led by University of Michigan · Updated on 2026-02-24

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This pilot study is designed to test the logistics and recruitment of a trial testing the benefit of sodium nitrate in the prevention of contrast-associated kidney injury in a group of patients at high-risk.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned coronary angiogram or contrast-enhanced CT scan.
  • High risk for contrast-associated acute kidney injury with recent creatinine or GFR test within 90 days as defined by:
    1. Coronary angiogram with GFR less than 45 mL/min/1.73m2 OR
    2. Coronary angiogram with GFR less than 60 mL/min/1.73m2 and AKI risk of 7% or higher by BMC2 risk model OR
    3. Contrast-enhanced CT scan with GFR less than 45 mL/min/1.73m2.
  • Women of childbearing potential agree to use highly effective contraception from screening through study participation.
  • Ability to take oral medication and willing to follow study treatment.
  • Ability to understand and agree to informed consent.
Not Eligible

You will not qualify if you...

  • Acute kidney injury already present before contrast exposure by KDIGO criteria.
  • Primary reason for procedure is PCI including acute ST-segment elevation myocardial infarction.
  • End-stage kidney disease on dialysis.
  • Received intravenous or intraarterial contrast within 5 days before planned procedure.
  • Cardiac arrest within 14 days before procedure.
  • Low blood pressure (systolic less than 100 mmHg or diastolic less than 60 mmHg) or currently on inotropes or vasopressors.
  • Allergy to study drug components including sodium nitrate, inorganic nitrate, beet root juice, or lactose (excluding lactose intolerance).
  • Pregnant or nursing women.
  • Participation in another investigational trial within 30 days prior to enrollment.
  • Use of tadalafil within 48 hours, sildenafil or vardenafil within 24 hours, or avanafil within 12 hours before starting study medication. Continuous use of these medications excludes participation; intermittent users must withhold use during treatment and 48 hours after last dose.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

A

Allison Schley

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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