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

Primary Purpose

Empagliflozin in Cardiorenal Syndrome Type 1

Status
Not yet recruiting
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Empagliflozin 10 MG
Placebo
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Empagliflozin in Cardiorenal Syndrome Type 1 focused on measuring Empagliflozin, SGLT2i, Cardiorenal syndrome, ADHF, AKI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Empagliflozin

Placebo

Arm Description

Empagliflozin 10 mg po OD

Matching placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

In-hospital mortality rate
In-hospital mortality rate
30-days mortality rate
30-days mortality rate
Initiation of Renal Replacement therapy
Initiation of Renal Replacement therapy
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
Recurrent heart failure
Recurrent heart failure required hospital administration
Vasoactive drug
Vasoactive drug use
Mechanical ventilation
Mechanical ventilation use
Ventricular tachycardia or ventricular fibrillation
Ventricular tachycardia or ventricular fibrillation
Resuscitation following a cardiac arrest
Resuscitation following a cardiac arrest
Reduction of prespecified renal biomarkers
Reduction of prespecified renal biomarkers

Full Information

First Posted
September 3, 2023
Last Updated
September 9, 2023
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT06030843
Brief Title
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Acronym
TREAT-CRS
Official Title
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Empagliflozin in Cardiorenal Syndrome Type 1
Keywords
Empagliflozin, SGLT2i, Cardiorenal syndrome, ADHF, AKI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin
Arm Type
Experimental
Arm Description
Empagliflozin 10 mg po OD
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
Empagliflozin 10 MG
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo containing Lactose content (0.26 gram)
Primary Outcome Measure Information:
Title
MAKE30
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
In-hospital mortality rate
Description
In-hospital mortality rate
Time Frame
During admission
Title
30-days mortality rate
Description
30-days mortality rate
Time Frame
30 days
Title
Initiation of Renal Replacement therapy
Description
Initiation of Renal Replacement therapy
Time Frame
30 days
Title
Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR
Description
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
Title
Recurrent heart failure
Description
Recurrent heart failure required hospital administration
Time Frame
30 days
Title
Vasoactive drug
Description
Vasoactive drug use
Time Frame
30 days
Title
Mechanical ventilation
Description
Mechanical ventilation use
Time Frame
30 days
Title
Ventricular tachycardia or ventricular fibrillation
Description
Ventricular tachycardia or ventricular fibrillation
Time Frame
30 days
Title
Resuscitation following a cardiac arrest
Description
Resuscitation following a cardiac arrest
Time Frame
30 days
Title
Reduction of prespecified renal biomarkers
Description
Reduction of prespecified renal biomarkers
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sasipha Tachaboon
Phone
022564000
Ext
3679
Email
sasipha_tac@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nattachai Srisawat
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
State/Province
Pathumwan
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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