RECRUITING Phase 3 ClinicalTrials.gov

Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure

Sponsor: Christian Schulze • ClinicalTrials.gov ID: NCT07038356

Registry updated: 2026-08-26

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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

Interventions

Empagliflozin 10 MG Oral Tablet [Jardiance] (Drug)
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 (Drug)
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

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

Conditions

Acute Decompensated Heart Failure (ADHF)

Locations

Jena University Hospital — Jena, Thuringia, Germany
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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment