Study on the Effects of Empagliflozin for Patients with Cardiogenic Shock

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What is this study about?

This clinical trial is focused on studying the effects of a medication called empagliflozin on patients experiencing cardiogenic shock. Cardiogenic shock is a serious condition where the heart suddenly can’t pump enough blood to meet the body’s needs. The medication being tested, empagliflozin, is a type of drug known as a sodium glucose cotransporter 2 (SGLT2) inhibitor, which is commonly used to treat diabetes. In this study, empagliflozin is being used to see if it can help improve outcomes for patients with cardiogenic shock.

The purpose of the study is to compare the effects of starting empagliflozin early, in addition to the usual treatment, versus the usual treatment alone. The study will last for about three months. During this time, researchers will look at several important health outcomes, such as survival rates, the need for rehospitalization, heart function, and kidney function. Participants will be randomly assigned to receive either empagliflozin along with their usual care or just the usual care without empagliflozin.

Throughout the study, doctors will monitor participants’ heart and kidney health, as well as other factors like weight and liver function. The goal is to see if adding empagliflozin to the treatment plan can improve the overall health and recovery of patients with cardiogenic shock. This research could provide valuable insights into new ways to support patients with this challenging condition.

1 joining the study

Upon joining the study, participation begins with a review of eligibility criteria. This includes being an adult aged 18 or older, hospitalized in a critical cardiac care unit or intensive care unit for cardiogenic shock, and having been on catecholamine for more than 12 hours.

2 randomization

Participants are randomly assigned to one of two groups: one group receives the usual management for cardiogenic shock, and the other group receives the usual management plus empagliflozin.

3 medication administration

For those in the empagliflozin group, the medication is administered orally in the form of Jardiance 10 mg film-coated tablets. The dosage and frequency are determined by the study protocol and medical team.

4 treatment period

The treatment period lasts for 12 weeks. During this time, participants continue with their assigned treatment regimen.

5 monitoring and assessments

Throughout the 12-week period, participants undergo regular monitoring and assessments. These include evaluations of heart function, such as left ventricular ejection fraction, and other health indicators like renal and liver function, weight, and NT-proBNP levels.

6 end of study assessments

At the end of the 12 weeks, final assessments are conducted. These include checking for any occurrences of death, heart transplant, or mechanical ventricular assistance, as well as rehospitalization for heart failure.

Who Can Join the Study?

  • Must be an adult who is 18 years old or older.
  • Must be hospitalized in a critical cardiac care unit or an intensive care unit due to cardiogenic shock. Cardiogenic shock is a condition where the heart suddenly can’t pump enough blood to meet the body’s needs.
  • Must have been receiving catecholamine for more than 12 hours. Catecholamine is a type of medication that helps the heart pump better.
  • Must be affiliated with a social security scheme, meaning they have some form of health insurance or social health coverage.

Who Cannot Join the Study?

  • Patients with Cardiogenic Shock cannot participate. This is a condition where the heart suddenly can’t pump enough blood to meet the body’s needs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre Hospital Region Metz Thionville Metz France
Cznbjv Hoovyweelki Uxlqmbmiyzbrn Rirop Reims France
Ctukxq Hhxqpzwrhnr Uojijfjyhwxep Ds Dixuc Dijon France
Bxsjczed Uydhzaahiy Hakilhto Cuhxur Besançon France
Ctme Du Nvbyz Vandoeuvre Les Nancy France
Hmkauwyo Uozhmdzobaomya Slawwasncs &ewhqyk Hjwjyvw dd Htzykkolenv STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.05.2024

Trial locations

Investigated drugs:

Empagliflozin is a medication used in this trial to assess its effects when introduced early in patients experiencing cardiogenic shock. It is being studied to see if it can improve outcomes such as reducing mortality, preventing rehospitalization, and improving heart and kidney function when added to the usual treatment.

Investigated diseases:

Cardiogenic Shock – Cardiogenic shock is a serious condition where the heart suddenly can’t pump enough blood to meet the body’s needs. It often occurs after a severe heart attack, but not everyone who has a heart attack will experience cardiogenic shock. The heart’s inability to pump effectively leads to a drop in blood pressure, reducing blood flow to vital organs. Symptoms may include rapid breathing, severe shortness of breath, and a weak pulse. As the condition progresses, it can cause confusion, loss of consciousness, and cold, clammy skin. Immediate medical attention is crucial to manage the symptoms and support heart function.

Trial ID:
2023-503602-37-00
Protocol code:
2021PI218
NCT ID:
NCT05879276
Trial Phase:
Therapeutic confirmatory (Phase III)

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