Kidney Week

Abstract: SA-OR015

Feasibility and Acceptability of a Randomized Clinical Trial of SGLT2 Inhibitors in Heart Failure-Associated AKI

Session Information

• AKI Trials, Therapeutics, and Risk Stratification
  October 24, 2026 | Location: Room 603, Convention Center
  Abstract Time: 05:20 PM - 05:30 PM

Category: Acute Kidney Injury

• 102 AKI: Clinical, Outcomes, and Trials

Authors

• Reed, Abigail, Yale School of Medicine, New Haven, Connecticut, United States

Abigail Reed

• Victoria Castro, Angela Maria, Yale School of Medicine, New Haven, Connecticut, United States

Angela Maria Victoria Castro, MD, MS

• Shelton, Kyra A., Yale School of Medicine, New Haven, Connecticut, United States

Kyra A. Shelton

• Martin, Melissa, Yale School of Medicine, New Haven, Connecticut, United States

Melissa Martin, MS

• Kent, Candice, Yale School of Medicine, New Haven, Connecticut, United States

Candice Kent, MS

• Wilson, Francis Perry, Yale School of Medicine, New Haven, Connecticut, United States

Francis Perry Wilson, MD, MS

• Aklilu, Abinet Mathias, Yale School of Medicine, New Haven, Connecticut, United States

Abinet Mathias Aklilu, MD, MPH

Background

SGLT2i are an effective treatment for CKD and heart failure. However, their safety and efficacy in AKI is unknown. Concern for worsening kidney function is a common reason for interruption and limited uptake.

Methods

We conducted a 1:1 open-label randomized clinical trial to test the feasibility, acceptability, and safety of SGLT2i in heart failure-associated AKI (NCT#06111768). Patients were initially screened based on an EHR alert system triggered when a hospitalized adult (18-85y/o) had an NT-proBNP >300pg/mL and AKI meeting ≥stage 1 KDIGO-sCr criteria. Further eligibility criteria (volume overload, baseline sCr adjudication, contraindications, other obvious causes for AKI) were confirmed by chart review. Key exclusion criteria were eGFR<25 ml/min/1.73m2, end-stage HF, and recent exposure to SLGT2i. Patients were randomized to dapagliflozin 10mg daily (SGLT2i) or usual care (UC) alone for 3 days and actively monitored for up to 4 days.

Results

Of 551 adults who met inclusion criteria (5/2024-9/2025), 54 were eligible. Reasons for exclusion are shown in Fig 1A. The trial acceptability was 93% as measured by providers' consent rate. A total of 30 inpatients were enrolled and randomized with a consent rate of 60%. Half had HFpEF; 47% had DMII, 2/3 had CKD and 28% had CKD3b/4. The lowest eGFR was 25.7mL/min/1.72m2, and lowest LVEF was 17% with median(IQR) LVEF of 47 (27—60)%.(Fig 1b) During the exposure period, the median (IQR) of SBP and MAP for UC were 93 (90—104) and 71(67—74) mmHg, and 104(97—122) and 79(72—86)mmHg in SGLT2i (p=0.026 for SBP, non-significant for MAP). Reported adverse events were relative hypotension (3/4 in UC, 1/2 SGLT2i requiring intervention) and polyuria (n=1, SGLT2i). There were no GU symptoms or ketoacidosis. There were no adverse events requiring study/drug cessation. More patients in UC required potassium repletion (8/15 vs 2/15). All participants had at least 2 samples of plasma and urine each for later biomarker analysis.

Conclusion

A randomized control trial of SGLT2i in hospitalized patients with heart failure-associated AKI is feasible and acceptable.

Funding

• Private Foundation Support