Acute Decompensated Heart Failure (ADHF)Phase 3EMPA-CONNCT07038356
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
A Phase 3 study testing Empagliflozin 10 MG Oral Tablet [Jardiance] in people with Acute Decompensated Heart Failure (ADHF), run by Christian Schulze at 12 sites in Germany.
Trial 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 patients is not inferior compared to therapy cessation during the acute heart failure hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure (ADHF)
- What is being tested?
- Empagliflozin 10 MG Oral Tablet [Jardiance]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 536 participants
- Where
- 12 sitesGermany
- Study dates
- 8 Dec 2025to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Germany12 sites, 12 recruiting
- Recruiting
Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
Andreas Rieth, Dr., +4960329966151, a.rieth@kerckhoff-klinik.de
- Recruiting
Deutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin
Berlin, 12203
Bettina Heidecker, PD Dr. med., +4930450513728, bettina.heidecker@dhzc-charite.de
- Recruiting
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II, Herzzentrum
Bonn, 53127
Georg Nickenig, Prof. Dr. med., +4922828715217, georg.nickenig@ukbonn.de
- Recruiting
Herzzentrum Dresden GmbH Universitaetsklinik
Dresden, 01307
Ephraim Winzer, Dr., +4935145025238, ephraim.winzer@tu-dresden.de
- Recruiting
Universitaetsmedizin Goettingen
Göttingen, 37075
Stephan von Haehling, Prof., +495513968196, stephan.von.haehling@med.uni-goettingen.de
- Recruiting
Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III
Halle, 06120
Daniel Sedding, Prof. Dr. med., +493455572601, Daniel.Sedding@uk-halle.de
- Recruiting
Jena University Hospital
Jena, Thuringia, 07747
Julian Westphal, Dr., 036419324199, Julian.Westphal@med.uni-jena.de
- Recruiting
Universitaetsklinikum Leipzig AöR
Leipzig, 04103
Rolf Wachter, Prof., +493419712825, rolf.wachter@medizin.uni-leipzig.de
- Recruiting
Herzzentrum Leipzig GmbH
Leipzig, 04289
Holger Thiele, Prof., +49341865252500, Holger.Thiele@helios-gesundheit.de
- Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, 55131
Moritz Brandt, Dr., +496131178176, moritz.brandt@unimedizin-mainz.de
- Recruiting
LMU Klinikum Muenchen AöR
München, 81377
Stefan Kääb, Prof., +4989440072310, stefan.kaab@med.uni-muenchen.de
- Recruiting
Rostock University Medical Center
Rostock, 18057
Hüseyin Ince, Prof., +493814947701, hueseyin.ince@med.uni-rostock.de
About this study
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.
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.
Read more
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
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Being tested
- Empagliflozin 10 MG Oral Tablet [Jardiance], Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MG Oral Tablet [Jardiance]Drug
Randomized treatment with 10 mg empagliflozin (Jardiance, 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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | 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. Receives: Drug: Placebo |
| intervention | Active comparator | 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 Receives: Drug: Empagliflozin 10 MG Oral Tablet [Jardiance] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four-step hierarchical composite primary endpoint; win ratio based on the following parameters (day 90): time to all-cause death, number of heart failure events per patient, time to first heart failure event, eGFR decrease from baseline to day 90
The study uses a four-step hierarchical composite primary endpoint (win ratio):
- time to all-cause death, days (day 90)
- number of heart failure events per patient (day 90)
- time to first heart failure event, days (day 90)
- eGFR decrease from baseline to day 90 (with a between-patient threshold defined as ≥5 ml/min/1.73 m²)
Measured: day 90
Secondary outcomes (20)
Cardiovascular and total mortality on day 90
Measured: day 90
Number of patients alive and without re-hospitalization on day 90
Measured: day 90
Re-hospitalization after initial discharge, including reason: time to first rehospitalization after discharge
Measured: day 90
Re-hospitalization after initial discharge, including reason: numbers of re-hospitalizations
Measured: day 90
Number of patients with a decrease in eGFR of 5 ml/min/1.73 m² or more from baseline to day 90
Measured: day 90
Daily and cumulative urine output (UOP, ml) measured from day 1 until day 6
Measured: day 1 until day 6
Diuretic efficiency (ml urine per mg furosemide equivalent) from day 1 to day 6
Measured: day 1 until day 6
Change in body weight from baseline to day 1, day 3, day 6, discharge (supposed between day 6-10), day 30, and day 90
Measured: day 1, day 3, day 6, discharge (supposed between day 6-10), day 30, and day 90
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
Measured: baseline, day 3, day 6, day 30, and day 90
Liver function: bilirubin (nmol/ml) at baseline, day 3, day 6, day 30, and day 90
Measured: baseline, day 3, day 6, day 30, and day 90
Liver function: serum aminotransferases (µmol/l*s) at baseline, day 3, day 6, day 30, and day 90
Measured: baseline, day 3, day 6, day 30, and day 90
Liver function: relevant change in coagulation status (Quick/INR, %, 3X upper limit of normal) at baseline, day 3, day 6, day 30, and day 90
Measured: baseline, day 3, day 6, day 30, and day 90
Change in NT-proBNP (N-terminal pro Brain natriuretic peptide, pg/ml) (alternatively calculated from BNP, Brain natriuretic peptide, pg/ml) from baseline to day 6, day 30, and day 90
Measured: baseline to day 6, day 30, and day 90
Quality of life (EQ-5D-3L questionnaire, 3-level version of the EuroQol five dimensional descriptive system ) on day 0, at hospital discharge (supposed between day 6-10), and on day 30
Quality of life: EQ-5D-3L questionaire. The EQ-5D-3L questionnaire consists of two parts: part one contains questions about patients mobility, self-care, usual activities, pain/discomfort, anxiety/depression, with scores from 1 (no problem), 2 (some problems), and 3 (extreme problems). Part two measures patients health on a scale from 0 (the worst imaginable health) to 100 (the best imaginable health), on day 0, at hospital discharge (supposed between day 6-10), and on day 30
Measured: day 0, at hospital discharge (supposed between day 6-10), and on day 30
Severity of heart failure (HF): KCCQ-12 questionnaire (Kansas City Cardiomyopathy Questionnaire comprising 12 items) on day 0, at hospital discharge (supposed between day 6-10), and on day 30
KCCQ-12 questionnaire: scores range from 0 to 100, with higher scores indicating better health status, on day 0, at hospital discharge (supposed between day 6-10), and on day 30
Measured: day 0, at hospital discharge (supposed between day 6-10), and on day 30
Intermediate Care Unit (IMC) / Intensive Care Unit (ICU) and hospital length of stay, days until discharge (supposed between day 6-10)
Measured: discharge (supposed between day 6-10)
Single parameters of primary endpoint: time to all-cause death (day 90)
Measured: day 90
Single parameters of primary endpoint: number of heart failure events per patient (day 90)
Measured: day 90
Single parameters of primary endpoint: time to first heart failure event (day 90)
Measured: day 90
Single parameters of primary endpoint: eGFR decrease from baseline to day 90 (ml/min/1.73 m²)
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start8 Dec 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart Failure (ADHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Schulze
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Schulze, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038356
- Sponsor's protocol ID
- EMPA-CON_ZKSJ0162
- Other IDs
- 2024-517977-26-00
- Acronym
- EMPA-CON
- Status last verified
- Nov 2026
- First submitted
- 23 May 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07038356
- Acronym / sponsor ID
- EMPA-CON / EMPA-CON_ZKSJ0162
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Christian SchulzeUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: PlaceboRandomized 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. |
| intervention | Active comparator | Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MG Oral Tablet [Jardiance]Randomized treatment with 10 mg empagliflozin (Jardiance, 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 | Drug | intervention |
| PlaceboRandomized 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 | Drug | control |
Primary outcome
Four-step hierarchical composite primary endpoint; win ratio based on the following parameters (day 90): time to all-cause death, number of heart failure events per patient, time to first heart failure event, eGFR decrease from baseline to day 90
Time frame: day 90
The study uses a four-step hierarchical composite primary endpoint (win ratio): 1. time to all-cause death, days (day 90) 2. number of heart failure events per patient (day 90) 3. time to first heart failure event, days (day 90) 4. eGFR decrease from baseline to day 90 (with a between-patient threshold defined as ≥5 ml/min/1.73 m²)
20 secondary outcomes
Cardiovascular and total mortality on day 90
Time frame: day 90
Number of patients alive and without re-hospitalization on day 90
Time frame: day 90
Re-hospitalization after initial discharge, including reason: time to first rehospitalization after discharge
Time frame: day 90
Re-hospitalization after initial discharge, including reason: numbers of re-hospitalizations
Time frame: day 90
Number of patients with a decrease in eGFR of 5 ml/min/1.73 m² or more from baseline to day 90
Time frame: day 90
Daily and cumulative urine output (UOP, ml) measured from day 1 until day 6
Time frame: day 1 until day 6
Diuretic efficiency (ml urine per mg furosemide equivalent) from day 1 to day 6
Time frame: day 1 until day 6
Change in body weight from baseline to day 1, day 3, day 6, discharge (supposed between day 6-10), day 30, and day 90
Time frame: day 1, day 3, day 6, discharge (supposed between day 6-10), day 30, and day 90
Renal function at baseline, day 3, day 6, day 30, and day 90
Time frame: baseline, day 3, day 6, day 30, and day 90
Liver function: bilirubin (nmol/ml) at baseline, day 3, day 6, day 30, and day 90
Time frame: baseline, day 3, day 6, day 30, and day 90
Liver function: serum aminotransferases (µmol/l*s) at baseline, day 3, day 6, day 30, and day 90
Time frame: baseline, day 3, day 6, day 30, and day 90
Liver function: relevant change in coagulation status (Quick/INR, %, 3X upper limit of normal) at baseline, day 3, day 6, day 30, and day 90
Time frame: baseline, day 3, day 6, day 30, and day 90
Change in NT-proBNP (N-terminal pro Brain natriuretic peptide, pg/ml) (alternatively calculated from BNP, Brain natriuretic peptide, pg/ml) from baseline to day 6, day 30, and day 90
Time frame: baseline to day 6, day 30, and day 90
Quality of life (EQ-5D-3L questionnaire, 3-level version of the EuroQol five dimensional descriptive system ) on day 0, at hospital discharge (supposed between day 6-10), and on day 30
Time frame: day 0, at hospital discharge (supposed between day 6-10), and on day 30
Severity of heart failure (HF): KCCQ-12 questionnaire (Kansas City Cardiomyopathy Questionnaire comprising 12 items) on day 0, at hospital discharge (supposed between day 6-10), and on day 30
Time frame: day 0, at hospital discharge (supposed between day 6-10), and on day 30
Intermediate Care Unit (IMC) / Intensive Care Unit (ICU) and hospital length of stay, days until discharge (supposed between day 6-10)
Time frame: discharge (supposed between day 6-10)
Single parameters of primary endpoint: time to all-cause death (day 90)
Time frame: day 90
Single parameters of primary endpoint: number of heart failure events per patient (day 90)
Time frame: day 90
Single parameters of primary endpoint: time to first heart failure event (day 90)
Time frame: day 90
Single parameters of primary endpoint: eGFR decrease from baseline to day 90 (ml/min/1.73 m²)
Time frame: day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin
Berlin, Germany
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin 10 MG Oral Tablet [Jardiance] in people with Acute Decompensated Heart Failure (ADHF), run by Christian Schulze at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Four-step hierarchical composite primary endpoint; win ratio based on the following parameters (day 90): time to all-cause death, number of heart failure events per patient, time to first heart failure event, eGFR decrease from baseline to day 90 (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.