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
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
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
Parallel
Empagliflozin 10 MG Oral Tablet [Jardiance]
DrugRandomized 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
DrugRandomized 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
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)
Cardiovascular and total mortality on day 90
Number of patients alive and without re-hospitalization on day 90
Re-hospitalization after initial discharge, including reason: time to first rehospitalization after discharge
Re-hospitalization after initial discharge, including reason: numbers of re-hospitalizations
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Christian Schulze
Lead sponsor
Jena University Hospital
Sponsor institution
