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Recruiting

NCT Number: NCT06030843

The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1

Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Medicine, Chulalongkorn University

Bangkok, Pathumwan, 10330, Thailand

Location status: Recruiting

Location contact

Tanat Lertussavavivat

CONTACT

[email protected]

6622564000 ext. 73303

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin 10 MG

Drug

Empagliflozin 10 MG

Placebo

Drug

Matching placebo containing Lactose content (0.26 gram)

Primary outcomes

  1. MAKE30

    Time frame: 30 days

    The composite outcome of death, new dialysis, and sustained loss of kidney function (which was defined as a 25% or greater decline in eGFR from baseline) assess at 30 days following randomization

Secondary outcomes

  1. In-hospital mortality rate

    Time frame: During admission

    In-hospital mortality rate

  2. 30-days mortality rate

    Time frame: 30 days

    30-days mortality rate

  3. Initiation of Renal Replacement therapy

    Time frame: 30 days

    Initiation of Renal Replacement therapy

  4. Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR

    Time frame: 30 days

    Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR

  5. Recurrent heart failure

    Time frame: 30 days

    Recurrent heart failure required hospital administration

  6. Vasoactive drug

    Time frame: 30 days

    Vasoactive drug use

  7. Mechanical ventilation

    Time frame: 30 days

    Mechanical ventilation use

  8. Ventricular tachycardia or ventricular fibrillation

    Time frame: 30 days

    Ventricular tachycardia or ventricular fibrillation

  9. Resuscitation following a cardiac arrest

    Time frame: 30 days

    Resuscitation following a cardiac arrest

  10. Reduction of prespecified renal biomarkers

    Time frame: 30 days

    Reduction of prespecified renal biomarkers

Study contacts

Contact information is provided by the study sponsor or research team.

Sasipha Tachaboon

CONTACT

[email protected]

6622564000 ext. 73305

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Acronym: TREAT-CRS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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