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Study on the Effects of Empagliflozin for Patients with Cardiogenic Shock

Verified siteRegistered drugNo placebo

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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 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 4
Treatment period
The treatment period lasts for 12 weeks. During this time, participants continue with their assigned treatment regimen.
Step 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.
Step 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 trial?

4 criteria

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 trial?

1 criterion

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
Verified
Besançon, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Centre Hospitalier Universitaire De Dijon
Verified
Dijon, France

Trial locations

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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.

Empagliflozin

What is already known about the treatment

Empagliflozin – Empagliflozin is administered orally in tablet form. It is currently being studied in clinical trials for its effects on patients with cardiogenic shock, a severe condition where the heart suddenly can't pump enough blood to meet the body's needs. The main therapeutic indication being explored is its potential to improve outcomes such as mortality, rehospitalization, and heart function in these patients. At the molecular level, empagliflozin works by inhibiting a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2), which reduces blood sugar levels by preventing glucose reabsorption. It is classified pharmacologically as an SGLT2 inhibitor, commonly used in the treatment of type 2 diabetes.

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.