NCT06030843 The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
| NCT ID | NCT06030843 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Chulalongkorn University |
| Condition | Empagliflozin in Cardiorenal Syndrome Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-03-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
Eligibility 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
Contact & Investigator
Nattachai Srisawat
PRINCIPAL INVESTIGATOR
Chulalongkorn University
Frequently Asked Questions
Who can join the NCT06030843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Empagliflozin in Cardiorenal Syndrome Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06030843 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06030843 currently recruiting?
Yes, NCT06030843 is actively recruiting participants. Contact the research team at sasipha.t@chulahospital.org for enrollment information.
Where is the NCT06030843 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT06030843 clinical trial?
NCT06030843 is sponsored by Chulalongkorn University. The principal investigator is Nattachai Srisawat at Chulalongkorn University. The trial plans to enroll 200 participants.