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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
536
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
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
Jena University Hospital
Jena, Thuringia, Germany
RECRUITINGKerckhoff-Klinik GmbH
Bad Nauheim, Germany
RECRUITINGDeutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin
Berlin, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Bonn, Medizinische Klinik und Poliklinik II, Herzzentrum
Bonn, Germany
RECRUITINGHerzzentrum Dresden GmbH Universitaetsklinik
Dresden, Germany
RECRUITINGUniversitaetsmedizin Goettingen
Göttingen, Germany
RECRUITINGUniversitätsklinikum Halle (Saale), Klinik für Innere Medizin III
Halle, Germany
NOT_YET_RECRUITINGUniversitaetsklinikum Leipzig AöR
Leipzig, Germany
RECRUITINGHerzzentrum Leipzig GmbH
Leipzig, Germany
RECRUITINGUniversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany
RECRUITING...and 2 more locations
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): 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)
Time frame: day 90
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
* 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
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.