Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07038356

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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