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Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure

RecruitingPhase 3Ages 18 Years - anyAllChristian Schulze
NCT07038356 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to test the hypothesis that the continuation of empagliflozin during decongestive therapy in the setting of acute decompensated and hospitalized heart failure patients is not inferior compared to therapy cessation during the acute heart failure hospitalization. Randomized treatment (plus standard medical care) in patients with acute decompensated heart failure is one (1) tablet daily of empagliflozin 10 mg or matching placebo during the in-hospital stay (up to a maximum of 30 days), followed by treatment with empagliflozin 10 mg daily after discharge (but no later than day 31) until day 90. The primary outcome measure is the combined hierarchical endpoint of all-cause mortality, heart failure hospitalization and worsening renal function at 90 days after admission. Secondary outcome measures are the effects on urine output, diuretic efficiency, qualit

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients (age ≥ 18 years) with acute decompensated heart failure (HF) according to clinical assessment on active therapy with a SGLT2 inhibitor * Brain Natriuretic Peptide (BNP) \>100 pg/ml or N-terminal pro-BNP (NTproBNP) \>300 pg/ml * Written informed consent obtained * Women of childbearing potential: negative pregnancy test and use of a highly effective method of contraception Exclusion Criteria: * Type 1 diabetes mellitus * Chronic Kidney Disease (CKD) with eGFR\<20 ml/min, or end-stage renal failure with the need for chronic dialysis treatment * Acute kidney injury (AKI) requiring dialysis treatment * Known intolerance to empagliflozin * Acute heart failure without signs of congestion ("dry" patient) * Need for hemofiltration or any other form of extracorporeal therapy * Previous participation in this trial or recent participation in another clinical trial (within the last 4 weeks before inclusion) * Identification of any causes of heart failure leading to decompensation that needs urgent management (like acute coronary syndrome, severe unstable arrhythmias, mechanical causes, acute pulmonary embolism) * Incapacity to understand and / or to provide written informed consent * Obvious uncontrolled substance abuse * Pregnancy, breastfeeding
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What it tests

  • Empagliflozin 10 MG Oral Tablet [Jardiance]
  • Placebo
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Where

12 sites
Jena University Hospital
Jena, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany
Deutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin
Berlin, Germany
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II, Herzzentrum
Bonn, Germany
Herzzentrum Dresden GmbH Universitaetsklinik
Dresden, Germany
Universitaetsmedizin Goettingen
Göttingen, Germany
Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III
Halle, Germany
Universitaetsklinikum Leipzig AöR
Leipzig, Germany

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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