Status:

RECRUITING

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

Lead Sponsor:

Christian Schulze

Conditions:

Acute Decompensated Heart Failure (ADHF)

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 patien...

Eligibility Criteria

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)
  • Indication for coronary angiography or any foreseeable administration of a contrast media
  • Need for hemofiltration or any other form of extracorporeal therapy
  • Planned surgery
  • 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

Key Trial Info

Start Date :

December 8 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

536 Patients enrolled

Trial Details

Trial ID

NCT07038356

Start Date

December 8 2025

End Date

June 30 2026

Last Update

April 1 2026

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Jena University Hospital

Jena, Thuringia, Germany, 07747

2

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany, 61231

3

Herzzentrum Dresden GmbH Universitaetsklinik

Dresden, Germany, 01307

4

Universitaetsmedizin Goettingen

Göttingen, Germany, 37075

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