Tests continuing empagliflozin in heart failure patients hospitalized with acute decompensation
Tests whether continuing empagliflozin during hospital care for acute heart failure is safe.
Key facts
- Who runs it
- Christian Schulze
- Where
- Bad Nauheim, Berlin, Bonn, Dresden, Goettingen, Greifswald, Halle (Saale), Jena, Leipzig, Magdeburg, Mainz, Munich, and Rostock, GermanySee the 14 sites
- Trial code
- Registry title
- Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 536 people, planned
- Started
- 8 Dec 2025
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Empagliflozin 10 MG Oral Tablet [Jardiance]
- Placebo
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in hospital with acute decompensated heart failure who are already taking an SGLT2 inhibitor. It tests whether continuing empagliflozin in hospital works as well as stopping it.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Acute decompensated heart failure with signs of congestion (fluid build-up), judged by a clinical assessment.
- Earlier treatment
- Must be taking an SGLT2 inhibitor at the moment.
- Biomarker or test result
- BNP above 100 pg/ml or NTproBNP above 300 pg/ml.
Main reasons for not taking part
- Type 1 diabetes
- Kidney disease with eGFR below 20 ml/min, or long-term dialysis
- Acute kidney injury that needs dialysis
- Known intolerance to empagliflozin
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Type 1 diabetes mellitus
- Acute heart failure without signs of congestion ("dry" patient)
- 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)
- 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
- Incapacity to understand and / or to provide written informed consent
- Obvious uncontrolled substance abuse
- Pregnancy, breastfeeding
Where in Germany
- Kerckhoff-Klinik GmbHBad Nauheim, GermanyTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Universitätsklinikum BonnBonn, GermanyTaking people
- Herzzentrum Dresden GmbH UniversitaetsklinikDresden, GermanyTaking people
- Universitaetsmedizin GoettingenGoettingen, GermanyTaking people
- Universitaetsmedizin Greifswald KöRGreifswald, GermanyTaking people
- Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), GermanyTaking people
- Universitaetsklinikum Jena KöRJena, GermanyTaking people
- Herzzentrum Leipzig GmbHLeipzig, GermanyTaking people
- Universitaetsklinikum Leipzig AorLeipzig, GermanyTaking people
- Otto Von Guericke Universitaet MagdeburgMagdeburg, GermanyTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
- Rostock University Medical CenterRostock, GermanyTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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, quality-of-life and the need for further administration of diuretics.
Participants will
* Take one tablet of study medication once daily (day 1 to day 90) * Restrict fluid intake to 1.5 liters of fluid per day and record the daily fluid intake for the study from day 1 to day 6 in the patient diary * Measure the urine output (day 1 to day 6) * Fill in Questionnaires (EQ-5D-3L (3-level version of the EuroQol five dimensional descriptive system), KCCQ-12 (Kansas City Cardiomyopathy Questionnaire comprising 12 items)) on day 0 (Baseline), at hospital discharge, and on day 30
The 2 groups in the trial
- controlPlacebo, for comparison
Randomized treatment with placebo (one tablet) daily from day 1 until the day of hospital discharge, but no longer than 30 days, followed by 10 mg empagliflozin (Jardiance, one tablet) daily until day 90.
Treatment: Placebo
- interventionExisting treatment, for comparison
Drug: Empagliflozin (10 mg/day), film-coated tablet Randomized treatment with 10 mg empagliflozin (Jardiance, one tablet) or placebo daily from day 1 until the day of hospital discharge, but no longer than 30 days, followed by 10 mg empagliflozin (Jardiance, one tablet) daily until day 90
Treatment: Empagliflozin 10 MG Oral Tablet [Jardiance]
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
- Plain-language title
- Tests continuing empagliflozin in heart failure patients hospitalized with acute decompensationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 November 2026