RecruitingPhase 3NCT07038356

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

Enrollment

536 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

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 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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether continuing the heart failure medication empagliflozin (an SGLT2 inhibitor — a pill that helps the kidneys remove excess fluid and sugar) when a patient is hospitalized for worsening heart failure is safe and beneficial. **You may be eligible if...** - You are 18 years old or older - You are admitted to the hospital with worsening heart failure - You were already taking an SGLT2 inhibitor before admission - Your BNP or NTproBNP (heart failure blood markers) are elevated **You may NOT be eligible if...** - You have severe kidney failure - Your blood pressure is dangerously low - You need urgent procedures like dialysis or mechanical heart support Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 10 MG Oral Tablet [Jardiance]

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

DRUGPlacebo

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


Locations(9)

Jena University Hospital

Jena, Thuringia, Germany

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany

Herzzentrum Dresden GmbH Universitaetsklinik

Dresden, Germany

Universitaetsmedizin Goettingen

Göttingen, 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

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NCT07038356


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