NCT07273838RecruitingPhase 2
Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
Sodium-Glucose Cotransporter-2 Inhibitor for Amelioration of Acute Cardiorenal Syndrome: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 8 Aug 2025
- Start date
- 5 Mar 2026
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Yale University
- Diseases
- Heart failure
- NCT number
- NCT07273838
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 130
- From 5 Mar 2026 to the primary completion date, 31 Aug 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Advanced kidney disease at baseline defined as baseline eGFR \< 25 ml/min/1.73m2
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Yale New Haven Hospital-St. Raphael Campus Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.