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

NCT07038356 | Recruiting Phase 3 DMC

• 2 other identifiers: EMPA-CON_ZKSJ01622024-517977-26-00
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 9

Brief 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

Conditions

Acute Decompensated Heart Failure (ADHF)

Outcome Measures

Primary Outcomes (1)

• Four-step hierarchical composite primary endpoint; win ratio based on the following parameters (day 90): time to all-cause death, number of heart failure events per patient, time to first heart failure event, eGFR decrease from baseline to day 90

  The study uses a four-step hierarchical composite primary endpoint (win ratio): 1. time to all-cause death, days (day 90) 2. number of heart failure events per patient (day 90) 3. time to first heart failure event, days (day 90) 4. eGFR decrease from baseline to day 90 (with a between-patient threshold defined as ≥5 ml/min/1.73 m²)

  day 90

Secondary Outcomes (20)

• Cardiovascular and total mortality on day 90

  day 90

• Number of patients alive and without re-hospitalization on day 90

  day 90

• Re-hospitalization after initial discharge, including reason: time to first rehospitalization after discharge

  day 90

• Re-hospitalization after initial discharge, including reason: numbers of re-hospitalizations

  day 90

• Number of patients with a decrease in eGFR of 5 ml/min/1.73 m² or more from baseline to day 90

  day 90

Study Arms (2)

control

PLACEBO COMPARATOR

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.

Drug: Placebo

intervention

ACTIVE COMPARATOR

Drug: Empagliflozin (10 mg/day), film-coated tablet Randomized treatment with 10 mg empagliflozin (Jardiance, one tablet) or placebo 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

Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]

Interventions

Empagliflozin 10 MG Oral Tablet [Jardiance] DRUG

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

intervention

Placebo DRUG

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

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Christian Schulze: lead

Study Sites (9)

Jena University Hospital

Jena, Thuringia, 07747, Germany

RECRUITING

Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

RECRUITING

Herzzentrum Dresden GmbH Universitaetsklinik

Dresden, 01307, Germany

NOT YET RECRUITING

Universitaetsmedizin Goettingen

Göttingen, 37075, Germany

NOT YET RECRUITING

Universitaetsklinikum Leipzig AöR

Leipzig, 04103, Germany

RECRUITING

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

NOT YET RECRUITING

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Mainz, 55131, Germany

NOT YET RECRUITING

LMU Klinikum Muenchen AöR

München, 81377, Germany

NOT YET RECRUITING

Rostock University Medical Center

Rostock, 18057, Germany

NOT YET RECRUITING

MeSH Terms

Interventions

empagliflozin; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Internal Medicine I at Jena University Hospital and Professor of Medicine at Friedrich Schiller University Jena

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 26, 2025
• Study Start: December 8, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

DE (9)