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

Sponsor

Chulalongkorn University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06030843

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Empagliflozin in Cardiorenal Syndrome Type 1	Drug: Empagliflozin 10 MG Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Empagliflozin

Empagliflozin 10 mg po OD

Drug: Empagliflozin 10 MG

Empagliflozin 10 MG

Placebo Comparator: Placebo

Matching placebo

Drug: Placebo

Matching placebo containing Lactose content (0.26 gram)

Outcome Measures

Primary Outcome Measures

MAKE30 [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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