Salt solution may shield kidneys during heart scans
NCT ID NCT07016074
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This study tests whether sodium nitrate, a natural salt, can prevent kidney injury caused by contrast dye used in heart and CT scans. Researchers will enroll 100 high-risk patients to see if the treatment is practical and effective. The goal is to find a simple, low-cost way to protect kidneys during these common procedures.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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