Recruiting NCT06030843
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin 10 MG, Placebo.
- Who it may be relevant to
- Registry conditions: Empagliflozin in Cardiorenal Syndrome Type 1. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
Interventions
- Drug Empagliflozin 10 MG
Empagliflozin 10 MG - Drug Placebo
Matching placebo containing Lactose content (0.26 gram)
Primary outcome measures
- MAKE30 [Time frame: 30 days]
Secondary outcome measures (10)
- In-hospital mortality rate [Time frame: During admission]
- 30-days mortality rate [Time frame: 30 days]
- Initiation of Renal Replacement therapy [Time frame: 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 [Time frame: 30 days]
- Recurrent heart failure [Time frame: 30 days]
- Vasoactive drug [Time frame: 30 days]
- Mechanical ventilation [Time frame: 30 days]
- Ventricular tachycardia or ventricular fibrillation [Time frame: 30 days]
- Resuscitation following a cardiac arrest [Time frame: 30 days]
- Reduction of prespecified renal biomarkers [Time frame: 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Faculty of Medicine, Chulalongkorn University — Bangkok
Identifiers
NCT: NCT06030843 · IRB 674/66