Continuing empagliflozin during hospitalization for acute decompensated heart failure
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
This trial tests whether people hospitalized with acute decompensated heart failure who are already taking empagliflozin do better if they keep taking it during their hospital stay and for 90 days afterward.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 536 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 9 sites (Jena, Thuringia and 8 other locations) |
| Trial ID | NCT07038356 on ClinicalTrials.gov |
What this trial studies
Adults hospitalized with acute decompensated heart failure who are already on an SGLT2 inhibitor are randomized to either continue empagliflozin 10 mg daily or receive matching placebo during the in-hospital stay (up to 30 days), followed by empagliflozin after discharge through day 90. The primary outcome is a combined hierarchical endpoint of all-cause mortality, heart failure rehospitalization, and worsening renal function at 90 days. Secondary outcomes include urine output, diuretic efficiency, quality of life, and additional need for diuretics. Key enrollment criteria include elevated BNP or NT-proBNP and exclusion of patients with type 1 diabetes, very low eGFR, dialysis, or intolerance to empagliflozin.
Who should consider this trial
Good fit: Adults hospitalized with acute decompensated heart failure who were already taking an SGLT2 inhibitor and meet the BNP/NT-proBNP and safety criteria are the intended participants.
Not a fit: Patients with type 1 diabetes, eGFR below 20 ml/min or on chronic dialysis, acute kidney injury requiring dialysis, those without signs of congestion, or those intolerant to empagliflozin are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, continuing empagliflozin during hospitalization could lower deaths, rehospitalizations, or kidney worsening after acute heart failure.
How similar studies have performed: Large trials have shown benefit of SGLT2 inhibitors in chronic heart failure, but randomized data specifically testing continuation versus temporary stopping during acute hospitalization are limited.
Eligibility criteria
Show full inclusion / exclusion 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)
* 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
Where this trial is running
Jena, Thuringia and 8 other locations
- Jena University Hospital — Jena, Thuringia, Germany (Recruiting)
- Kerckhoff-Klinik GmbH — Bad Nauheim, Germany (Recruiting)
- Herzzentrum Dresden GmbH Universitaetsklinik — Dresden, Germany (Not_yet_recruiting)
- Universitaetsmedizin Goettingen — Göttingen, Germany (Not_yet_recruiting)
- Universitaetsklinikum Leipzig AöR — Leipzig, Germany (Recruiting)
- Herzzentrum Leipzig GmbH — Leipzig, Germany (Not_yet_recruiting)
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR — Mainz, Germany (Not_yet_recruiting)
- LMU Klinikum Muenchen AöR — München, Germany (Not_yet_recruiting)
- Rostock University Medical Center — Rostock, Germany (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.