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Study of empagliflozin compared to placebo in patients with acute decompensated heart failure who are already taking SGLT2 inhibitors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with acute decompensated heart failure, a condition where the heart suddenly cannot pump blood effectively, leading to severe symptoms. The study examines the effects of continuing treatment with empagliflozin, a medication that helps remove excess sugar from the body through urination, in patients who are already using similar medications when they are admitted to the hospital for heart failure symptoms.

The research aims to determine if continuing to take empagliflozin 10 mg tablets is as safe and effective as taking a placebo along with standard medical care. The study will monitor patients for 90 days after their hospital admission. During this time, participants will receive either empagliflozin film-coated tablets or matching placebo tablets taken by mouth.

Throughout the study, doctors will track several important health measures, including survival rates, hospital readmissions, and kidney function. Patients will have regular check-ups to monitor their heart and kidney function, body weight, and overall health status. They will also complete questionnaires about their quality of life and heart failure symptoms at various points during the study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Assessment

    After admission for acute decompensated heart failure, you will undergo initial evaluation

    Medical staff will verify your current use of SGLT2 inhibitor medication

    Blood tests will be performed to check BNP (Brain Natriuretic Peptide) or NT-proBNP levels

  2. Step 2

    Medication Assignment

    You will receive either empagliflozin 10 mg tablets or placebo tablets for oral use

    The tablets should be taken once daily

    Standard medical care for heart failure will continue throughout the study

  3. Step 3

    Initial Hospital Stay Monitoring (Days 1-6)

    Daily measurements of urine output

    Body weight checks on day 1, 3, and 6

    Blood tests for kidney and liver function on day 3 and 6

    Completion of quality of life questionnaires before discharge

  4. Step 4

    30-Day Follow-up

    Visit for medical assessment

    Blood tests for kidney and liver function

    Measurement of body weight

    Completion of quality of life questionnaires

  5. Step 5

    90-Day Final Assessment

    Final medical evaluation

    Blood tests for kidney and liver function

    Measurement of body weight

    Assessment of heart failure events and hospitalizations during the study period

Who can join the trial?

7 criteria

  • Must be 18 years of age or older
  • Must have acute decompensated heart failure (a severe worsening of heart failure symptoms that requires immediate medical attention)
  • Must be currently taking SGLT2 inhibitor medication (a type of diabetes medication that also helps treat heart failure)
  • Must have elevated levels of heart failure markers in blood: - BNP greater than 100 pg/ml (Brain Natriuretic Peptide - a hormone that increases when heart failure worsens) OR - NT-proBNP greater than 300 pg/ml (another form of the hormone that indicates heart failure severity)
  • Must be able to provide written informed consent (formal agreement to participate in the study)
  • For women who can become pregnant, must have a negative pregnancy test
  • Both men and women can participate in the study

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Currently pregnant or breastfeeding women
  • Known allergy or sensitivity to empagliflozin (the study medication)
  • Severe kidney disease requiring dialysis
  • Type 1 diabetes
  • Active liver disease or severe liver dysfunction
  • Recent heart attack (within last 30 days)
  • Systolic blood pressure below 90 mmHg (low blood pressure)
  • Recent stroke (within last 3 months)
  • Life-threatening conditions requiring immediate intensive care
  • Participation in another clinical trial within the past 30 days
  • Unable to provide informed consent
  • History of ketoacidosis (a serious complication where the blood becomes too acidic)
  • Severe urinary tract infection or genital infection
  • Taking medications that may interact with the study drug
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Investigated drugs

  • Empagliflozin

    This medication belongs to a group called SGLT2 inhibitors. It is used to treat heart failure. The medication works by helping the kidneys remove excess sugar from the blood through urine. In this trial, it is being studied to see if continuing its use during hospital stays for worsening heart failure is beneficial for patients who were already taking SGLT2 inhibitors before being admitted to the hospital.

  • SGLT2 inhibitors

    This is a class of medications that help control blood sugar levels and can improve heart function. These medications work by preventing the kidneys from reabsorbing sugar back into the blood, instead allowing it to be removed through urine. Patients in this trial were already using these medications before their hospital admission for heart failure symptoms.

What is already known about the treatment

Empagliflozin - An oral medication belonging to the class of SGLT2 (sodium-glucose co-transporter-2) inhibitors that is taken as a tablet once daily. This medication works by helping the kidneys remove excess glucose from the blood through urination, while also having beneficial effects on heart function and blood pressure. It is primarily used to treat heart failure and type 2 diabetes, with clinical evidence showing significant benefits in reducing hospitalization rates for heart failure and cardiovascular-related deaths. The drug has become an important part of standard heart failure treatment protocols, particularly for patients with reduced ejection fraction, and continues to be studied in clinical trials for acute decompensated heart failure management.

Investigated diseases

Acute Decompensated Heart Failure - A severe condition where the heart suddenly cannot pump blood effectively enough to meet the body's needs. It occurs when chronic heart failure worsens or develops rapidly, leading to fluid buildup in the lungs and other body tissues. The main symptoms include severe shortness of breath, rapid or irregular heartbeat, and swelling in the legs and ankles. This condition typically causes fatigue and difficulty breathing, especially when lying down. The heart's reduced pumping ability leads to congestion in various parts of the body, causing fluid retention and decreased organ function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517977-26-00Protocol codeEMPA-CON_ZKSJ0162Estimated enrolment556 patientsSponsorFriedrich-Schiller-Universitaet Jena

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