Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
NCT07273838 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2026-03-13
Summary
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
Interventions
- DRUG
-
Dapagliflozin 10mg Tab
Administration of 10mg oral dapagliflozin once daily for 14 days (or until discharge).
- DRUG
-
Administration of placebo comparator once daily for 14 days (or until discharge).
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
Yale University
lead OTHER
Principal Investigators
-
Abinet Aklilu, MD · Yale University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-05
- Primary Completion
- 2028-08-31
- Completion
- 2029-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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