Status:
ACTIVE_NOT_RECRUITING
Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study
Lead Sponsor:
Yale University
Collaborating Sponsors:
American Heart Association
Conditions:
Cardiorenal Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The long-term objective of this study is to test whether the addition of SGLT2 inhibitors to usual care during acute heart failure management in patients who develop kidney injury shortens the time to...
Detailed Description
Acute heart failure is associated with a significant risk of acute kidney injury which is present in up to a third of patients at the time of hospitalization. As adequate kidney function is necessary ...
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
- NT-proBNP \> 300 pg/mL
- Ability to take an oral medication
- Willing to adhere to the SGLT2i + usual care regimen
Exclusion
- Current use of SGLT2 inhibitor or use in the past 72 hours
- Pregnancy or lactation (a pregnancy test will be performed 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 past 6 months or 3 x in the past 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
Key Trial Info
Start Date :
May 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06111768
Start Date
May 30 2024
End Date
May 1 2026
Last Update
December 4 2025
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520