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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Empagliflozin in Cardiorenal Syndrome Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Empagliflozin

Empagliflozin 10 mg po OD

Group Type EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type DRUG

Empagliflozin 10 MG

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo containing Lactose content (0.26 gram)

Interventions

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Empagliflozin 10 MG

Intervention Type DRUG

Placebo

Matching placebo containing Lactose content (0.26 gram)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No