Actively Recruiting
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Led by Christian Schulze · Updated on 2026-04-01
536
Participants Needed
9
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
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
CONDITIONS
Official Title
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older with acute decompensated heart failure on active SGLT2 inhibitor therapy
- Brain Natriuretic Peptide (BNP) greater than 100 pg/ml or N-terminal pro-BNP (NTproBNP) greater than 300 pg/ml
- Written informed consent provided
- Women of childbearing potential must have a negative pregnancy test and use a highly effective contraception method
You will not qualify if you...
- Type 1 diabetes mellitus
- Chronic kidney disease with eGFR below 20 ml/min or requiring chronic dialysis
- Acute kidney injury requiring dialysis
- Known intolerance to empagliflozin
- Acute heart failure without congestion signs
- Need for coronary angiography or administration of contrast media
- Need for hemofiltration or extracorporeal therapy
- Planned surgery
- Participation in this or another clinical trial within the last 4 weeks
- Heart failure due to urgent causes like acute coronary syndrome or severe arrhythmias
- Inability to understand or provide informed consent
- Uncontrolled substance abuse
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Jena University Hospital
Jena, Thuringia, Germany, 07747
Actively Recruiting
2
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany, 61231
Actively Recruiting
3
Herzzentrum Dresden GmbH Universitaetsklinik
Dresden, Germany, 01307
Not Yet Recruiting
4
Universitaetsmedizin Goettingen
Göttingen, Germany, 37075
Not Yet Recruiting
5
Universitaetsklinikum Leipzig AöR
Leipzig, Germany, 04103
Actively Recruiting
6
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Not Yet Recruiting
7
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany, 55131
Not Yet Recruiting
8
LMU Klinikum Muenchen AöR
München, Germany, 81377
Not Yet Recruiting
9
Rostock University Medical Center
Rostock, Germany, 18057
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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