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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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