The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1 (TREAT-CRS)

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

Study Overview

• Status: Recruiting
• Conditions: Empagliflozin in Cardiorenal Syndrome Type 1
• Intervention / Treatment: Drug: Empagliflozin 10 MG; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sasipha Tachaboon; Phone Number: 73305 6622564000; Email: sasipha.t@chulahospital.org

Study Locations

• Thailand
  • Pathumwan
    • Bangkok, Pathumwan, Thailand, 10330
      • Recruiting
      • Faculty of Medicine, Chulalongkorn University
      • Contact: Tanat Lertussavavivat; Phone Number: 73303 6622564000; Email: lert.tanat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Matching placebo containing Lactose content (0.26 gram)
Experimental: Empagliflozin; Empagliflozin 10 mg po OD	Drug: Empagliflozin 10 MG; Empagliflozin 10 MG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAKE30	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality rate	In-hospital mortality rate	During admission
30-days mortality rate	30-days mortality rate	30 days
Initiation of Renal Replacement therapy	Initiation of Renal Replacement therapy	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	Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR	30 days
Recurrent heart failure	Recurrent heart failure required hospital administration	30 days
Vasoactive drug	Vasoactive drug use	30 days
Mechanical ventilation	Mechanical ventilation use	30 days
Ventricular tachycardia or ventricular fibrillation	Ventricular tachycardia or ventricular fibrillation	30 days
Resuscitation following a cardiac arrest	Resuscitation following a cardiac arrest	30 days
Reduction of prespecified renal biomarkers	Reduction of prespecified renal biomarkers	30 days

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Nattachai Srisawat, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 3, 2023
• First Submitted That Met QC Criteria: September 3, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Empagliflozin; SGLT2i; AKI; ADHF; Cardiorenal syndrome
• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Disease; Renal Insufficiency; Heart Failure; Syndrome; Cardio-Renal Syndrome; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin
• Other Study ID Numbers: IRB 674/66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes