Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Recruiting · NCT07038356 · Interventional (participants receive a specific treatment) · Lead sponsor: Christian Schulze
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Where it is running
12 locations listed.
- Kerckhoff-Klinik GmbH - Bad Nauheim, Germany
- Deutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin - Berlin, Germany
- Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II, Herzzentrum - Bonn, Germany
- Herzzentrum Dresden GmbH Universitaetsklinik - Dresden, Germany
- Universitaetsmedizin Goettingen - Göttingen, Germany
- Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III - Halle, Germany
- Universitaetsklinikum Leipzig AöR - Leipzig, Germany
- Herzzentrum Leipzig GmbH - Leipzig, Germany
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR - Mainz, Germany
- LMU Klinikum Muenchen AöR - München, Germany
- Rostock University Medical Center - Rostock, Germany
- Jena University Hospital - Jena, Thuringia, Germany