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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie	Lublin	Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Umlccdyyjymtpo Cilcedr Moaovwee Mrytnyxw I Tcfkjtxzqwf	Gdynia	Poland
Rfsxkdzmbb Cfrqlif Kkvkwwihdzyt I Kfnqrmqrjaaqyiv	Mielec	Poland
Kkjc Kzucfulxr Vismcnau Jdtvrkhszlw	Czestochowa	Poland
Pbtbbwque Ioewrrux Mkwnjuvz Mdfqbykygxpb Slllz Wtevdfrobprz I Avvinrcslktdi	Warsaw	Poland
Ukhikcuxgtvdmh Cahbsex Kopynklun	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.09.2022

Trial locations

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.

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 ID:

2024-518685-27-00

Protocol code:

EMPATHY

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?