Actively Recruiting
Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
Led by Yale University · Updated on 2026-03-13
130
Participants Needed
2
Research Sites
190 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial 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). 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.
CONDITIONS
Official Title
Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness to comply with study procedures and availability for study duration
- Male or female aged 18 to 85 years
- Diagnosed with heart failure with preserved or reduced left ventricular function
- Signs of heart failure worsening
- Ability to take oral medication
- Willing to follow SGLT2 inhibitor or placebo treatment
You will not qualify if you...
- AKI caused primarily by another condition
- Current use or recent exposure (past 72 hours) to SGLT2 inhibitors
- Pregnancy or breastfeeding
- Known allergy to SGLT2 inhibitor components
- Use of other investigational heart failure drugs within 72 hours before AKI
- History of ileal conduit (neobladder)
- No way to collect urine (incontinence without catheter)
- Advanced kidney disease with baseline eGFR below 25 ml/min/1.73m2
- Unexplained low blood sugar in past 30 days
- History of Fournier's gangrene
- Recurrent urinary tract infections (2 or more in 6 months or 3 or more in 12 months)
- End-stage kidney disease requiring dialysis
- Very low urine output (oliguria)
- Severe AKI needing dialysis
- Currently on dialysis for AKI
- Receiving comfort care only
- Solid organ transplant on immunosuppressive therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Yale New Haven Hospital-St. Raphael Campus
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
A
Abinet Aklilu, MD
CONTACT
F
Francis Wilson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here