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

ConditionEmpagliflozin in Cardiorenal Syndrome Type 1
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 10 MG

    Drug

    Empagliflozin 10 MG

  • Placebo

    Drug

    Matching placebo containing Lactose content (0.26 gram)

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: EmpagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 days

Secondary outcomes

1

In-hospital mortality rate

In-hospital mortality rate

Time frame
During admission
2

30-days mortality rate

30-days mortality rate

Time frame
30 days
3

Initiation of Renal Replacement therapy

Initiation of Renal Replacement therapy

Time frame
30 days
4

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

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

Source ClinicalTrials.gov
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