Could a diabetes pill help heal heart and kidney damage at the same time?
NCT ID NCT07273838
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding an SGLT2 inhibitor (a type of diabetes medicine) to standard hospital care helps people with heart failure who also develop acute kidney injury. Researchers will compare outcomes like survival, need for dialysis, and symptom relief between those who get the drug and those who get a placebo. About 130 adults with worsening heart failure are being recruited.
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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 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Oct 2029
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 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥ 18 and ≤ 85 years-old * Diagnosed with heart failure of either preserved or reduced left ventricular function * Have signs of heart failure exacerbation * Ability to take an oral medication * Willing to adhere to the SGLT2i vs placebo regimen Exclusion Criteria: * AKI can be primarily explained by another etiology * Current use of SGLT2 inhibitor or exposure in the past 72 hours * Pregnancy or lactation (pregnancy test prior to enrollment in women of child-bearing age) * Known allergic reactions to components of an SGLT2 inhibitor * Treatment with another investigational drug for heart failure different from or in addition to usual care within the 72 hours preceding AKI * Any individual who meets any of the following criteria will be excluded from participation in this study: * Documented history of ileal conduit (neobladder) * No means of collecting urine such as patients with documented incontinence without indwelling or external urinary catheter * Advanced kidney disease at baseline defined as baseline eGFR \< 25 ml/min/1.73m2 * Unexplained hypoglycemia in the past 30 days from enrollment * History of Fournier's gangrene (pelvic necrotizing fasciitis) * History of recurrent urinary tract infection (UTI): defined as documented UTI at least 2x in the preceding 6 months or 3 x in the preceding 12 months * End-stage kidney disease with dialysis requirement * Oliguria: defined as less than 30 ml urine output per hour for more than two consecutive hours or less than 500 ml over the preceding 24 hours * Severe acute kidney injury with indications for dialysis * Current dialysis receipt for acute kidney injury * Comfort measures only * Solid organ transplant on immunosuppression
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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
2 sites. 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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Yale New Haven Hospital
RECRUITINGNew Haven, Connecticut, 06510, United States
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Yale New Haven Hospital-St. Raphael Campus
RECRUITINGNew Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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- Can daily mindful breathing ease heart failure symptoms?