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NCT Number: NCT07038356

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

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

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Key information

Conditions

Acute Decompensated Heart Failure (ADHF)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jena University Hospital, Jena, Thuringia, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

    Time frame: day 90

    The study uses a four-step hierarchical composite primary endpoint (win ratio):

    • time to all-cause death, days (day 90)
    • number of heart failure events per patient (day 90)
    • time to first heart failure event, days (day 90)
    • eGFR decrease from baseline to day 90 (with a between-patient threshold defined as ≥5 ml/min/1.73 m²)

Secondary outcomes

  1. Cardiovascular and total mortality on day 90

    Time frame: day 90

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

    Time frame: day 90

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

    Time frame: day 90

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

    Time frame: day 90

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

    Time frame: day 90

  6. Daily and cumulative urine output (UOP, ml) measured from day 1 until day 6

    Time frame: day 1 until day 6

  7. Diuretic efficiency (ml urine per mg furosemide equivalent) from day 1 to day 6

    Time frame: day 1 until day 6

  8. Change in body weight from baseline to day 1, day 3, day 6, discharge (supposed between day 6-10), day 30, and day 90

    Time frame: day 1, day 3, day 6, discharge (supposed between day 6-10), day 30, and day 90

  9. Renal function at baseline, day 3, day 6, day 30, and day 90

    Time frame: baseline, day 3, day 6, day 30, and day 90

    • Decrease in eGFR of >20 ml/min/1.73 m2
    • Doubling of serum creatinine
    • Need for renal replacement therapy
    • Total urinary sodium excretion and fractional excretion of sodium

  10. Liver function: bilirubin (nmol/ml) at baseline, day 3, day 6, day 30, and day 90

    Time frame: baseline, day 3, day 6, day 30, and day 90

  11. Liver function: serum aminotransferases (µmol/l*s) at baseline, day 3, day 6, day 30, and day 90

    Time frame: baseline, day 3, day 6, day 30, and day 90

  12. Liver function: relevant change in coagulation status (Quick/INR, %, 3X upper limit of normal) at baseline, day 3, day 6, day 30, and day 90

    Time frame: baseline, day 3, day 6, day 30, and day 90

  13. Change in NT-proBNP (N-terminal pro Brain natriuretic peptide, pg/ml) (alternatively calculated from BNP, Brain natriuretic peptide, pg/ml) from baseline to day 6, day 30, and day 90

    Time frame: baseline to day 6, day 30, and day 90

  14. Quality of life (EQ-5D-3L questionnaire, 3-level version of the EuroQol five dimensional descriptive system ) on day 0, at hospital discharge (supposed between day 6-10), and on day 30

    Time frame: day 0, at hospital discharge (supposed between day 6-10), and on day 30

    Quality of life: EQ-5D-3L questionaire. The EQ-5D-3L questionnaire consists of two parts: part one contains questions about patients mobility, self-care, usual activities, pain/discomfort, anxiety/depression, with scores from 1 (no problem), 2 (some problems), and 3 (extreme problems). Part two measures patients health on a scale from 0 (the worst imaginable health) to 100 (the best imaginable health), on day 0, at hospital discharge (supposed between day 6-10), and on day 30

  15. Severity of heart failure (HF): KCCQ-12 questionnaire (Kansas City Cardiomyopathy Questionnaire comprising 12 items) on day 0, at hospital discharge (supposed between day 6-10), and on day 30

    Time frame: day 0, at hospital discharge (supposed between day 6-10), and on day 30

    KCCQ-12 questionnaire: scores range from 0 to 100, with higher scores indicating better health status, on day 0, at hospital discharge (supposed between day 6-10), and on day 30

  16. Intermediate Care Unit (IMC) / Intensive Care Unit (ICU) and hospital length of stay, days until discharge (supposed between day 6-10)

    Time frame: discharge (supposed between day 6-10)

  17. Single parameters of primary endpoint: time to all-cause death (day 90)

    Time frame: day 90

  18. Single parameters of primary endpoint: number of heart failure events per patient (day 90)

    Time frame: day 90

  19. Single parameters of primary endpoint: time to first heart failure event (day 90)

    Time frame: day 90

  20. Single parameters of primary endpoint: eGFR decrease from baseline to day 90 (ml/min/1.73 m²)

    Time frame: day 90

Sponsors and collaborators

Lead sponsor

Christian Schulze

Other

Registry information

Acronym: EMPA-CON

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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