Sodium nitrate to prevent contrast-associated acute kidney injury
Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
This pilot will test whether taking sodium nitrate around the time of a coronary angiogram or contrast-enhanced CT can prevent contrast-associated acute kidney injury in people at high risk.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07016074 on ClinicalTrials.gov |
What this trial studies
This Phase 2 pilot tests the logistics and recruitment for using oral sodium nitrate as a preventive measure against contrast-associated acute kidney injury in high-risk patients undergoing coronary angiography or contrast-enhanced CT. Participants are assigned to receive sodium nitrate or a matching placebo around the time of their contrast exposure, with baseline and follow-up blood tests to monitor kidney function. Follow-up creatinine testing is scheduled at about 72 hours (±36 hours) after contrast to allow flexible outpatient lab completion while still capturing expected kidney function changes. The focus is both on feasibility and on collecting preliminary signals of safety and potential efficacy to inform larger trials.
Who should consider this trial
Good fit: People scheduled for a coronary angiogram or contrast-enhanced CT who are at high risk for contrast-associated acute kidney injury (for example, GFR <45 mL/min/1.73m2, or GFR <60 with additional risk factors) who can take oral medication and provide informed consent.
Not a fit: Patients who already meet criteria for acute kidney injury before contrast exposure, those with low baseline risk for contrast-associated kidney injury, or those unable to take oral medication or follow study procedures are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, sodium nitrate could lower the incidence of contrast-associated acute kidney injury and reduce related complications after angiography or CT scans.
How similar studies have performed: Some preclinical work and small early-phase human studies suggest inorganic nitrate can affect vascular and renal physiology, but using sodium nitrate specifically to prevent contrast-associated AKI remains relatively novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Planned coronary angiogram or contrast-enhanced CT scan.
* High-risk for contrast-associated acute kidney injury (AKI) with creatine/Glomerular filtration 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 of AKI 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 of highly effective contraception starting at screening and during study participation.
* Ability to take oral medication and be willing to adhere to the study intervention regimen.
* Ability to understand and willingness to agree to an informed consent
Exclusion Criteria:
* Already fulfilling definition of acute kidney injury prior to contrast exposure by kidney disease improving global outcomes (KDIGO) criteria (absolute increase in creatinine 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 acute ST-segment elevation myocardial infarction
* End-stage renal disease actively on dialysis.
* Received any intravenous or intraarterial contrast within five days from planned contrast administration.
* Cardiac arrest within 14 days of planned contrast administration.
* Systolic blood pressure \< 100mmHg or diastolic blood pressure \<60mmHg OR currently receiving inotropes or vasopressors for hemodynamic support.
* History of hypersensitivity or known allergy to any of the components of the investigational product or placebo including sodium nitrate, inorganic nitrate, beet root juice, or lactose. This does not include lactose intolerance.
* Pregnancy or nursing female
* Participation in other investigational trials within the past 30 days prior to enrollment.
* Use of tadalafil within 48 hours, sildenafil or vardenafil within 24 hours, and avanafil within 12 hours of initiation of trial medication. If participant is on continuous dosing of tadalafil, sildenafil, vardenafil, or avanafil, they will be excluded from the trial. If participant is on intermittent dosing of tadalafil, sildenafil, vardenafil, or avanafil, patient agrees to withhold use of medication for duration of medication treatment extending 48 hours after the final dose.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: David Hamilton, MD — University of Michigan
- Study coordinator: Allison Schley
- Email: schleya@umich.edu
- Phone: 734-232-9051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.