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Study on Empagliflozin and Dapagliflozin for Patients Hospitalized with Acute Heart Failure

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What is this trial about?

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

This clinical trial is focused on studying the effects of two medications, Empagliflozin and Dapagliflozin, in patients who have been hospitalized due to a condition known as acute heart failure. Acute heart failure occurs when the heart suddenly becomes unable to pump blood effectively, leading to symptoms like shortness of breath and fluid buildup. The purpose of the study is to investigate how these medications, which belong to a class of drugs called SGLT-2 inhibitors, can impact the health outcomes of these patients.

Participants in the study will receive either Empagliflozin, Dapagliflozin, or a placebo, which is a substance with no active medication. The study will last for several months, during which time the health of the participants will be closely monitored. The researchers aim to see if these medications can reduce the risk of complications such as worsening heart failure or the need for additional hospital visits. The study will also look at other health factors, including kidney function and overall quality of life.

Throughout the study, participants will undergo regular check-ups and tests to assess their heart function and overall health. The results will help determine if Empagliflozin and Dapagliflozin can be effective treatments for improving outcomes in patients with acute heart failure. This research could provide valuable insights into managing this serious condition and potentially lead to better treatment options in the future.

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

    Joining the trial

    Upon joining the trial, you will be asked to provide written informed consent. This means you agree to participate after understanding the trial's purpose and procedures.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either the medication dapagliflozin, empagliflozin, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drugs.

  3. Step 3

    Medication administration

    If you are assigned to receive dapagliflozin or empagliflozin, you will take the medication orally. The dosage is 10 mg once daily. The duration of administration will be determined by the trial protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. This includes regular check-ups and tests to assess your heart condition and overall health. You will be observed for any changes in symptoms or side effects.

  5. Step 5

    End of trial participation

    At the end of your participation, you will undergo a final assessment. This will help determine the effects of the medication on your heart condition.

Who can join the trial?

10 criteria

  • Patients must be at least 18 years old and able to provide written consent to participate.
  • Patients must have a kidney function test result called eGFR greater than 20 ml/min/1.73m². This test measures how well the kidneys are working.
  • Patients must be currently hospitalized with a primary diagnosis of acute/decompensated heart failure, which includes symptoms of fluid buildup in the body.
  • For patients with a type of heart failure called HFpEF, the diagnosis must be confirmed by tests that show changes in the heart's structure or function.
  • Patients must be randomized into the study no earlier than 24 hours and up to 10 days after their initial hospital admission, while still in the hospital.
  • Patients must be stable, meaning their systolic blood pressure (the top number in a blood pressure reading) is greater than 100 mmHg for at least the last 6 hours.
  • Patients must not have had an increase in intravenous (IV) diuretics, which are medications that help remove excess fluid, in the last 6 hours.
  • Patients must not have used IV vasodilators, which are medications that help widen blood vessels, in the last 6 hours.
  • Patients must not have used IV inotropes or a medication called levosimendan in the last 24 hours before being randomized.
  • Patients must have elevated levels of a heart-related protein called NT-proBNP during their current hospital stay. The required levels are more than 600 pg/mL for patients with HFrEF, more than 300 pg/mL for patients with HFmrEF or HFpEF, or more than 900 pg/mL if they have a heart rhythm issue called atrial fibrillation at admission.

Who cannot join the trial?

1 criterion

  • Patients with acute/decompensated heart failure cannot participate. This means if your heart is not pumping blood as well as it should, especially if this condition has suddenly worsened, you are not eligible.
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Investigated drugs

  • Empagliflozin

    is a medication that helps the body remove excess sugar through urine. It is used to treat heart failure by helping the heart pump blood more effectively. In this trial, it is being studied to see how it affects patients who have been hospitalized for heart failure, regardless of their heart's pumping ability or whether they have diabetes.

  • Dapagliflozin

    is another medication that helps lower blood sugar levels by removing sugar through urine. It is also used to treat heart failure by improving the heart's function. This trial is examining how dapagliflozin impacts patients who are in the hospital due to heart failure, regardless of their heart's pumping capacity or diabetes status.

What is already known about the treatment

  • Empagliflozin

    Empagliflozin is taken orally in the form of a tablet. It is currently being studied in clinical trials for its effects on heart failure, specifically in patients with acute or worsening heart failure. The main therapeutic use of Empagliflozin is to help manage heart failure symptoms and improve heart function. It works by blocking a protein in the kidneys called SGLT-2, which helps remove excess glucose and sodium from the body, reducing the workload on the heart. Empagliflozin is classified as an SGLT-2 inhibitor.

  • Dapagliflozin

    Dapagliflozin is administered orally as a tablet. It is under investigation in clinical trials for its potential benefits in treating heart failure, particularly in patients experiencing acute or worsening heart failure. The primary therapeutic indication for Dapagliflozin is to alleviate heart failure symptoms and enhance heart performance. It functions by inhibiting the SGLT-2 protein in the kidneys, promoting the excretion of excess glucose and sodium, thereby easing the heart's burden. Dapagliflozin belongs to the class of SGLT-2 inhibitors.

Investigated diseases

Acute Decompensated Heart Failure – Acute decompensated heart failure is a sudden worsening of the symptoms of heart failure, which can include shortness of breath, swelling of the legs and feet, and fatigue. This condition occurs when the heart is unable to pump blood effectively, leading to a buildup of fluid in the lungs and other parts of the body. The progression involves an increase in the severity of symptoms, often requiring urgent medical attention. It can be triggered by various factors such as infections, uncontrolled high blood pressure, or heart attacks. Over time, the heart's ability to function may continue to decline, leading to more frequent episodes. Management focuses on stabilizing the patient and addressing the underlying causes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518685-27-00Protocol codeEMPATHYEstimated enrolment1 364 patientsSponsorMedical University Of Warsaw

sourced from the EU Clinical Trials Register and site verification

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