Tests dapagliflozin in hospital patients with heart failure and acute kidney injury
Tests dapagliflozin added to usual care in hospitalized adults with heart failure and kidney injury.
Plain-language title generated from the registry record
Registry title: Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
Key facts
- Where
- New Haven, United StatesSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07273838, who can take part
Where in United States
- Yale New Haven HospitalNew Haven, United StatesTaking people
- Yale New Haven Hospital-St. Raphael CampusNew Haven, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yale University
- Trial code
- NCT07273838
- Record updated
- 13 March 2026
- Original description
The overall objective of this study is to determine whether the addition of SGLT2 inhibitors to usual care in hospitalized patients with heart failure associated acute kidney injury is safe and efficacious. Investigators will assess if SGLT2 inhibition improves a composite cardio-renal outcome (mortality, dialysis, AKI progression, decongestion metrics, heart failure symptoms). Secondary objectives of this study are to compare individual components of the composite outcome as well as changes in biomarkers of kidney injury, inflammation, repair and oxidative stress between those exposed to the SGLT2 inhibitor vs placebo.Read full original descriptionShow less
Sodium-Glucose Cotransporter-2 Inhibitor for Amelioration of Acute Cardiorenal Syndrome: A Randomized Controlled Trial
The overall objective of this study is to determine whether the addition of SGLT2 inhibitors to usual care in hospitalized patients with heart failure associated acute kidney injury is safe and efficacious. Investigators will assess if SGLT2 inhibition improves a composite cardio-renal outcome (mortality, dialysis, AKI progression, decongestion metrics, heart failure symptoms). Secondary objectives of this study are to compare individual components of the composite outcome as well as changes in biomarkers of kidney injury, inflammation, repair and oxidative stress between those exposed to the SGLT2 inhibitor vs placebo.
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: 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); Treatment with another investigational drug for heart failure different from or in addition to usual care within the 72 hours preceding AKI; Solid organ transplant on immunosuppression; Known allergic reactions to components of an SGLT2 inhibitor; Documented history of ileal conduit (neobladder); 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; Advanced kidney disease at baseline defined as baseline eGFR < 25 ml/min/1.73m2; AKI can be primarily explained by another etiology; Any individual who meets any of the following criteria will be excluded from participation in this study:; No means of collecting urine such as patients with documented incontinence without indwelling or external urinary catheter; Unexplained hypoglycemia in the past 30 days from enrollment; 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.