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Dapagliflozin for Heart Failure and Acute Kidney Injury

This study is looking at whether adding a medication called dapagliflozin (10mg tablet) to usual care is safe and effective for people in the hospital with heart failure and acute kidney injury (sudden kidney damage). Participants will receive either dapagliflozin or a placebo (an inactive pill) once daily for up to 14 days, or until they leave the hospital. We want to see if dapagliflozin improves a combined measure of heart and kidney health, including things like survival, needing dialysis, and heart failure symptoms. You may be able to join if you are 18 to 85 years old, have been diagnosed with heart failure, show signs of worsening heart failure, and can take oral medication. The study aims to understand if dapagliflozin can help patients with kidney injury related to heart failure.

Study design
This is an interventional study planning to enroll 130 participants. Participants will be randomly assigned to receive either dapagliflozin or a placebo.
What's involved
You would take an oral medication (dapagliflozin or placebo) once daily for 14 days or until discharge from the hospital.
Compensation
Not stated in the trial record.
Follow-up
Your cardio-renal clinical improvement will be measured at 30 days after you are randomly assigned to a treatment group.

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NCT07273838

Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome

Recruiting
PHASE2Ages 18–85InterventionalTreatment
Yale University
~130 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Dapagliflozin 10mg TabPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cardio-renal clinical improvement calculated as a Win Ratio
Measured over Calculated at 30 days post-randomization

Conditions

Heart Failure
Acute Kidney Injury

Explore related trials

Acute Renal FailureCardiorenal SyndromeHeart Failure

Where it's being run

2 sites across 1 states
Connecticut2

Study leadership

  • Abinet Aklilu, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Abinet Aklilu, MD
[email protected]
203-931-5064
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Cardio-renal clinical improvement calculated as a Win RatioCalculated at 30 days post-randomization

    This outcome is assessed using a win ratio (total wins in the intervention group divided by total wins in the control group). Pairwise comparisons of predetermined components are made between each participant in the intervention and control group hierarchically in order of clinical importance, with a "win" assigned to the participant with the more favorable result at the first level of difference. The win ratio is the number of "winning" pairs for the treatment group divided by the number of "losing" pairs, with a win ratio greater than 1 indicating a benefit for the treatment.