Clinical trial • Phase III • Cardiology
EMPAGLIFLOZIN for Acute decompensated heart failure
Phase III trial of EMPAGLIFLOZIN for Acute decompensated heart failure.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Acute decompensated heart failure
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-06-2025
- First CTIS Authorization Date
- 20-08-2025
Trial design
Randomised, open-label, control arm: matching placebo tablet, matching film-coated tablets for oral use, administered once a day orally during the in-hospital stay or until day 30. active arm: empagliflozin 10 mg once daily orally during the in-hospital stay or until day 30; after discharge (from day 31 to day 90) all participants receive open-label empagliflozin 10 mg daily. Phase III trial across 11 sites in Germany.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control arm: matching placebo tablet, matching film-coated tablets for oral use, administered once a day orally during the in-hospital stay or until day 30. Active arm: empagliflozin 10 mg once daily orally during the in-hospital stay or until day 30; after discharge (from day 31 to day 90) all participants receive open-label empagliflozin 10 mg daily.
- Target Sample Size
- 556
- Trial Duration For Participant
- 90
Eligibility
Recruits 556 Vulnerable populations not selected. Inclusion requires: "Written informed consent obtained". Exclusion: "Incapacity to understand and / or to provide written informed consent". Participants must be age ≥ 18 years..
- Pregnancy Exclusion
- Pregnancy, breastfeeding
- Vulnerable Population
- Vulnerable populations not selected. Inclusion requires: "Written informed consent obtained". Exclusion: "Incapacity to understand and / or to provide written informed consent". Participants must be age ≥ 18 years.
Inclusion criteria
- {"criterion_text":"- Patients (age ≥ 18 years) with acute decompensated heart failure (HF) according to clinical assessment on active therapy with a SGLT2 inhibitor"}
- {"criterion_text":"- Brain Natriuretic Peptide (BNP) >100 pg/ml or N-terminal pro-BNP (NT-proBNP) >300 pg/ml"}
- {"criterion_text":"- Written informed consent obtained"}
- {"criterion_text":"- Negative pregnancy test for women of childbearing potential"}
Exclusion criteria
- {"criterion_text":"- Type 1 diabetes mellitus"}
- {"criterion_text":"- 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)"}
- {"criterion_text":"- Incapacity to understand and / or to provide written informed consent"}
- {"criterion_text":"- Obvious uncontrolled substance abuse"}
- {"criterion_text":"- Pregnancy, breastfeeding"}
- {"criterion_text":"- Chronic Kidney Disease (CKD) with eGFR<20 ml/min, or end-stage renal failure with the need for chronic dialysis treatment"}
- {"criterion_text":"- Acute kidney injury (AKI) requiring dialysis treatment"}
- {"criterion_text":"- Known intolerance to empagliflozin"}
- {"criterion_text":"- Acute heart failure without signs of congestion (“dry” patient)"}
- {"criterion_text":"- Indication for coronary angiography or any foreseeable administration of a contrast media"}
- {"criterion_text":"- Need for hemofiltration or any other form of extracorporeal therapy"}
- {"criterion_text":"- Planned surgery"}
- {"criterion_text":"- Previous participation in this trial or recent participation in another clinical trial (within the last 4 weeks before inclusion)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The study uses a four-step hierarchical composite primary endpoint: 1) time to all-cause death (day 90) 2) number of heart failure events per patient (day 90) 3) time to first heart failure event (day 90) 4) eGFR decrease from baseline to day 90 (with a between-patient threshold defined as ≥5 ml/min/1.73 m²)","definition_or_measurement_approach":"Four-step hierarchical composite assessed at day 90 consisting of: 1) time to all-cause death (day 90); 2) number of heart failure events per patient (day 90); 3) time to first heart failure event (day 90); 4) eGFR decrease from baseline to day 90 with a between-patient threshold defined as ≥5 ml/min/1.73 m²."}
Secondary endpoints
- {"endpoint_text":"- Cardiovascular and total mortality on day 90","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of patients alive and without re-hospitalization on day 90","definition_or_measurement_approach":""}
- {"endpoint_text":"- Re-hospitalization after initial discharge, including reason (time to first re-hospitalization after discharge, numbers of re-hospitalizations)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of patients with a decrease in eGFR of 5 ml/min/1.73 m² or more from baseline to day 90","definition_or_measurement_approach":""}
- {"endpoint_text":"- Daily and cumulative urine output (UOP) measured from day 1 to day 6","definition_or_measurement_approach":""}
- {"endpoint_text":"- Diuretic efficiency (ml urine per mg furosemide equivalent) from day 1 to day 6","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change in body weight from baseline to day 1, day 3, day 6, discharge, day 30, and day 90","definition_or_measurement_approach":""}
- {"endpoint_text":"- Renal function at baseline, day 3, day 6, day 30, and day 90 : •Decrease in eGFR of >20 ml/min/1.73 m2 •Doubling of serum creatinine •Need for renal replacement therapy •Total urinary sodium excretion and fractional excretion of sodium","definition_or_measurement_approach":""}
- {"endpoint_text":"- Liver function (bilirubin, serum aminotransferases, relevant change in coagulation status) at baseline, day 3, day 6, day 30, and day 90","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change in NT-proBNP (alternatively calculated from BNP) from baseline to day 6, day 30, and day 90","definition_or_measurement_approach":""}
- {"endpoint_text":"- Quality of life (EQ-5D-3L questionnaire) on day 0, at hospital discharge, and on day 30","definition_or_measurement_approach":""}
- {"endpoint_text":"- Severity of HF (KCCQ-12 questionnaire) on day 0, at hospital discharge, and on day 30","definition_or_measurement_approach":""}
- {"endpoint_text":"- IMC / ICU and hospital length of stay","definition_or_measurement_approach":""}
- {"endpoint_text":"- Single parameters of primary endpoint","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 556
- Recruitment Window Months
- 21
- Consent Approach
- Written informed consent obtained from each participant (inclusion criterion: "Written informed consent obtained"). Participants must be ≥ 18 years. Exclusion includes: "Incapacity to understand and / or to provide written informed consent". Subject information and informed consent form documents are referenced (e.g. L1_SIS and ICF).
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 556
Germany
- Earliest CTIS Part Ii Submission Date
- 28-07-2025
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 268
- Number Of Sites
- 11
- Number Of Participants
- 556
Sites
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Julian Westphal
- Principal Investigator Email
- Julian.Westphal@med.uni-jena.de
- Contact Person Name
- Julian Westphal
- Contact Person Email
- Julian.Westphal@med.uni-jena.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Universitätsklinik für Kardiologie und Angiologie (KKAR)
- Principal Investigator Name
- Mariam Janashia
- Principal Investigator Email
- mariam.janashia@med.ovgu.de
- Contact Person Name
- Mariam Janashia
- Contact Person Email
- mariam.janashia@med.ovgu.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Metabolische Kardiologie
- Principal Investigator Name
- Stephan von Haehling
- Principal Investigator Email
- stephan.von.haehling@med.uni-goettingen.de
- Contact Person Name
- Stephan von Haehling
- Contact Person Email
- stephan.von.haehling@med.uni-goettingen.de
- Site Name
- Universitätsklinikum Bonn
- Department Name
- Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Georg Nickenig
- Principal Investigator Email
- georg.nickenig@ukbonn.de
- Contact Person Name
- Georg Nickenig
- Contact Person Email
- georg.nickenig@ukbonn.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Stefan Kääb
- Principal Investigator Email
- stefan.kaab@med.uni-muenchen.de
- Contact Person Name
- Stefan Kääb
- Contact Person Email
- stefan.kaab@med.uni-muenchen.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Zentrum für Kardiologie
- Principal Investigator Name
- Moritz Brandt
- Principal Investigator Email
- moritz.brandt@unimedizin-mainz.de
- Contact Person Name
- Moritz Brandt
- Contact Person Email
- moritz.brandt@unimedizin-mainz.de
- Site Name
- Herzzentrum Dresden GmbH Universitaetsklinik
- Department Name
- Klinik für Innere Medizin und Kardiologie
- Principal Investigator Name
- Ephraim Winzer
- Principal Investigator Email
- ephraim.winzer@tu-dresden.de
- Contact Person Name
- Ephraim Winzer
- Contact Person Email
- ephraim.winzer@tu-dresden.de
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Klinik und Poliklinik für Kardiologie
- Principal Investigator Name
- Rolf Wachter
- Principal Investigator Email
- rolf.wachter@medizin.uni-leipzig.de
- Contact Person Name
- Rolf Wachter
- Contact Person Email
- rolf.wachter@medizin.uni-leipzig.de
- Site Name
- Rostock University Medical Center
- Department Name
- Klinik und Poliklinik für Kardiologie
- Principal Investigator Name
- Hüseyin Ince
- Principal Investigator Email
- hueseyin.ince@med.uni-rostock.de
- Contact Person Name
- Hüseyin Ince
- Contact Person Email
- hueseyin.ince@med.uni-rostock.de
- Site Name
- Kerckhoff-Klinik GmbH
- Department Name
- Kardiologie
- Principal Investigator Name
- Andreas Rieth
- Principal Investigator Email
- a.rieth@kerckhoff-klinik.de
- Contact Person Name
- Andreas Rieth
- Contact Person Email
- a.rieth@kerckhoff-klinik.de
- Site Name
- Herzzentrum Leipzig GmbH
- Department Name
- Kardiologie
- Principal Investigator Name
- Holger Thiele
- Principal Investigator Email
- Holger.Thiele@helios-gesundheit.de
- Contact Person Name
- Holger Thiele
- Contact Person Email
- Holger.Thiele@helios-gesundheit.de
Sponsor
Primary sponsor
- Full Name
- Friedrich-Schiller-Universitaet Jena
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Third parties
- {"country":"Germany","full_name":"Universitaetsklinikum Jena KöR","duties_or_roles":"[1,10,11,12,5,6,8,9]","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Boehringer Ingelheim International GmbH, Binger Straße 173, 55216 Ingelheim am Rhein, Germany","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Jardiance 10 mg film-coated tablets
- Active Substance
- EMPAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (EU/1/14/930/018)
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
- Frequency
- Once daily
- Maximum Dose
- 10 mg daily
- Investigational Product Name
- Placebo tablet, matching film-coated tablets for oral use
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- Oral
- Frequency
- Once daily
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