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

Phase 2

Not yet recruiting

• Conditions: Empagliflozin in Cardiorenal Syndrome Type 1
• Interventions: Drug: Empagliflozin 10 MG; Drug: Placebo

• Registration Number: NCT06030843
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-03
• Study First Submitted QC: 2023-09-03
• Study First Posted: 2023-09-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Study Start: 2024-03
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin 10 MG	Empagliflozin 10 mg po OD
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mechanical ventilation	30 days	Mechanical ventilation use
Recurrent heart failure	30 days	Recurrent heart failure required hospital administration
Ventricular tachycardia or ventricular fibrillation	30 days	Ventricular tachycardia or ventricular fibrillation
Reduction of prespecified renal biomarkers	30 days	Reduction of prespecified renal biomarkers
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
Vasoactive drug	30 days	Vasoactive drug use
Resuscitation following a cardiac arrest	30 days	Resuscitation following a cardiac arrest

Trial Locations

Locations (1)

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Pathumwan, Thailand