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

Launched by CHRISTIAN SCHULZE · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether continuing a medicine called empagliflozin during hospital treatment for sudden worsening of heart failure is as safe and effective as stopping it temporarily. Empagliflozin is a type of drug that helps manage heart failure by supporting the heart and kidneys. The study will look at patients who are already taking this medicine but need to be hospitalized due to worsening symptoms. Researchers want to see if keeping the medication going during the hospital stay affects important outcomes like survival, the need for further hospital visits, and kidney health over the next three months.

To take part, patients must be adults with a recent worsening of heart failure who are already on empagliflozin or a similar drug. They also need certain blood test results that show heart failure is active. During the study, participants will take one tablet daily—either empagliflozin or a placebo (a pill with no medicine)—for up to 30 days in the hospital and continue for 90 days after leaving. They will also be asked to limit their fluid intake, track how much they drink and urinate, and complete simple questionnaires about their health and well-being at different times. The study is not yet recruiting, and some people won’t be able to join, such as those with very severe kidney problems, type 1 diabetes, or other serious health issues. This trial aims to help doctors understand the best way to manage heart failure medicines during hospital stays to improve patient outcomes.

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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
• • Negative pregnancy test for women of childbearing potential
• 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 administration of a contrast media
• • Need for hemofiltration or any other form of extracorporeal therapy
• • Planned surgery
• • 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