Continuing empagliflozin during hospitalization for acute decompensated heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults hospitalized with acute decompensated heart failure who are already on an SGLT2 inhibitor are randomized to either continue empagliflozin 10 mg daily or receive matching placebo during the in-hospital stay (up to 30 days), followed by empagliflozin after discharge through day 90. The primary outcome is a combined hierarchical endpoint of all-cause mortality, heart failure rehospitalization, and worsening renal function at 90 days. Secondary outcomes include urine output, diuretic efficiency, quality of life, and additional need for diuretics. Key enrollment criteria include elevated BNP or NT-proBNP and exclusion of patients with type 1 diabetes, very low eGFR, dialysis, or intolerance to empagliflozin.

Why it matters

Who can join: the full rules

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

Where it's running

• Jena University Hospital
  Jena, Thuringia, Germany Recruiting
• Kerckhoff-Klinik GmbH
  Bad Nauheim, Germany Recruiting
• Deutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin
  Berlin, Germany Recruiting
• Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II, Herzzentrum
  Bonn, Germany Recruiting
• Herzzentrum Dresden GmbH Universitaetsklinik
  Dresden, Germany Recruiting
• Universitaetsmedizin Goettingen
  Göttingen, Germany Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.