NCT07273838 · Yale University
Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
What this study is about
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).
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Haven, Connecticut
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations