Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
NCT ID: NCT07038356
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
536 participants
INTERVENTIONAL
2025-12-08
2026-06-30
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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control
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.
Placebo
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
intervention
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
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
Interventions
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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
Placebo
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Christian Schulze
OTHER
Responsible Party
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Christian Schulze
Director of Department of Internal Medicine I at Jena University Hospital and Professor of Medicine at Friedrich Schiller University Jena
Locations
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Jena University Hospital
Jena, Thuringia, Germany
Countries
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Facility Contacts
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Other Identifiers
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2024-517977-26-00
Identifier Type: CTIS
Identifier Source: secondary_id
EMPA-CON_ZKSJ0162
Identifier Type: -
Identifier Source: org_study_id