Empagliflozin for kidney protection in cardiorenal syndrome type 1
Official title: The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Run by Chulalongkorn University · NCT06030843 · Data updated 2026-11-12
This trial will test whether taking empagliflozin 10 mg compared with placebo helps protect the kidneys in adults hospitalized with acute heart failure who develop acute kidney injury.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Bangkok, Pathumwan) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT06030843 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) hospitalized for acute de novo or decompensated chronic heart failure who develop AKI by KDIGO criteria or have urine NGAL ≥150 ng/mL and can be enrolled within 12 hours are the intended participants.
✕Probably not a fit
Patients with AKI due to causes other than cardiorenal syndrome (for example sepsis or nephrotoxins), those who are anuric, already on or expected to require dialysis within 24 hours, hemodynamically unstable, with baseline eGFR ≤20 ml/min/1.73m2, recent SGLT2 inhibitor use, or prior heart or kidney transplant are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional Phase 2/3 trial compares empagliflozin 10 mg to a matching placebo in adults hospitalized with acute de novo or decompensated chronic heart failure who develop acute kidney injury or have elevated urine NGAL. Participants must be enrolled within 12 hours of AKI diagnosis or a urine NGAL ≥ 150 ng/mL. The main outcome is major adverse kidney events at 30 days (MAKE30), and the intervention is given during the acute hospitalization period. Patients with other causes of AKI, hemodynamic instability, recent SGLT2 inhibitor use, or need for immediate dialysis are excluded.
Why it matters
Potential benefit: If successful, empagliflozin could reduce short-term kidney complications such as the need for dialysis and improve 30-day kidney outcomes in patients with cardiorenal syndrome type 1.
How similar studies have gone: SGLT2 inhibitors have shown kidney and heart benefits in chronic heart failure and chronic kidney disease, but their use specifically in acute cardiorenal syndrome type 1 is less well tested and remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * Age 18 years or more * Hospitalized for the primary diagnosis of acute denovo or decompensated chronic heart regardless of ejection fraction * AKI KDIGO any stage or urine NGAL ≥ 150 ng/mL * Must be able to be enrolled into the trial ≤ 12 hours of diagnosis of AKI or elevated urine NGAL Exclusion criteria * Denied to participate in the study * Cardiogenic shock or unstable hemodynamic (systolic blood pressure of at least 100 mmHg or required inotropic support within last 24 hours) * Cardiac mechanical support (i.e. extracorporeal membrane oxygenation and intra-aortic balloon pump) * Acute coronary syndrome * Diagnosed with cause of AKI other than cardiorenal syndrome (eg. sepsis, nephrotoxic, dehydration) * Anuria or requiring dialysis or expected to required dialysis within 24 hr * Baseline eGFR ≤ 20 ml/min/1.73m2 with or without dialysis initiated * Heart or kidney transplanted * Previously received any SGLT2i in the last 3 months before admission * Allergic to any SGLT2i * Type 1 diabetes mellitus * History of ketoacidosis, including diabetic ketoacidosis * Pregnancy * Comorbid conditions with an expected survival of less than 1 months such as end-stage liver or heart disease, or uncurable malignancy
Where it's running
-
Faculty of Medicine, Chulalongkorn University
Bangkok, Pathumwan, Thailand Recruiting
Study contacts
- Principal investigator: Nattachai Srisawat — Chulalongkorn University
- Study coordinator: Sasipha Tachaboon
- Email: sasipha.t@chulahospital.org
- Phone: 6622564000
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.