Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Act
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 (p
| Condition(s) | Acute Decompensated Heart Failure (ADHF) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. 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 a |
| Who can participate | 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) * Indication for coronary angiography or any foreseeable admin |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Christian Schulze |
| Locations | Jena, Thuringia, Germany; Bad Nauheim, Germany; Dresden, Germany; Göttingen, Germany; Leipzig, Germany; Leipzig, Germany (+3 more sites) |
| Start date | 2025-12-08 |
| NCT ID | NCT07038356 |
| Official listing | https://clinicaltrials.gov/study/NCT07038356 |