Active not recruitingOBSERVATIONAL

Effect of Early Empagliflozin Initiation in Cardiogenic Shock.

This study is about a very serious heart problem called cardiogenic shock, where the heart can't pump enough blood. Sadly, many people don't recover well from this, and current treatments can have side effects. Researchers are looking at a newer type of medicine called SGLT2 inhibitors (like empagliflozin), which are already used for long-term heart failure. They've been good at reducing deaths and hospital stays. This study aims to find out if giving one of these medicines, empagliflozin, early to people with cardiogenic shock, in addition to their usual care, can improve their chances of survival and reduce readmissions to hospital over 12 weeks, compared to just having usual care.

At a glance

Status

Active not recruiting

Sponsor

Central Hospital, Nancy, France

Enrolment target

418

Start

10 Mar 2025

Estimated completion

01 Apr 2026

Cardiogenic Shock

What is this study about?

When your heart is very poorly and can't pump enough blood around your body, it's called cardiogenic shock. It's a very serious condition, and despite doctors' best efforts, it can be very dangerous. Researchers are always looking for better ways to help people get through this.

Recently, a new group of medicines called SGLT2 inhibitors (one example is empagliflozin) has been very helpful for people with long-term heart failure. These medicines have shown promise in reducing the number of people who pass away or need to go back into hospital because of their heart condition. Doctors are now wondering if these same benefits could help people who are experiencing cardiogenic shock, especially because these medicines are generally well-tolerated.

This study wants to learn more about this. The main goal is to see if giving empagliflozin early on to people with cardiogenic shock, alongside their usual medical care, makes a difference. They'll compare this to just giving people the usual care to see if adding empagliflozin helps reduce deaths and hospital readmissions for heart problems over a 12-week period.

Key takeaways

This study focuses on a serious heart problem called cardiogenic shock.
It investigates if an existing heart medicine (empagliflozin) helps when given early.
The goal is to see if it reduces deaths and hospital stays over 12 weeks.
The study uses existing patient records, so no new tests or medicines for participants.
Findings could improve future care for people with heart conditions.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and be in hospital in an Intensive Care Unit (ICU) or Cardiac Intensive Care Unit (CICU) because of cardiogenic shock. You also need to have been admitted to the CHRU of NANCY hospital between January 1, 2018, and December 31, 2023.

There are also some reasons why you wouldn't be able to join. For example, if your kidney function is very low or if you're already receiving dialysis treatment. You also wouldn't be eligible if you were already taking an SGLT2 inhibitor medicine before you were admitted to intensive care.

Certain types of cardiogenic shock, like those because of pregnancy, specific rare heart muscle diseases, drug-related heart damage, or if you had a very long cardiac arrest, would also mean you couldn't take part. Also, if you have a legal guardian or similar protective measure, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Were you in intensive care for cardiogenic shock?
Were you admitted to CHRU of NANCY hospital between 2018 and 2023?
Did you have normal kidney function (not on dialysis)?
Were you NOT taking an SGLT2 inhibitor before being admitted?

Answer every question to see your result.

What does participation involve?

This study looks back at information from patients who have already been treated. This means you wouldn't need to do anything extra or have any special visits if you were included. The researchers would simply be reviewing your existing medical records from your time in hospital and your follow-up care to see how you recovered and if you were readmitted to hospital within 12 weeks. You would not be given any new medication as part of this study.

Potential risks and benefits

Because this study looks back at existing medical information, there are no new medical risks or benefits to you directly. The potential benefit is that the findings from this study could help doctors better treat future patients with cardiogenic shock. You have the right to withdraw your consent for your past medical information to be used in this study at any time without it affecting your medical care.

Locations (1)

Chru Nancy
Verified postcode
Vandœuvre-lès-Nancy, France

Common questions

What is cardiogenic shock?

It's a serious condition where your heart can't pump enough blood to your body, often needing intensive medical care.

What are SGLT2 inhibitors?

These are medicines, like empagliflozin, that help people with heart failure by reducing strain on the heart.

Will I take this medicine if I join the study?

No, this study is looking at information from people who have already been treated, so you wouldn't take any study medicine.

Who is running this study?

The study is being organised by researchers hoping to improve care for people with serious heart conditions.

How long does this study last?

The study aims to look at patient outcomes for 12 weeks after their hospital admission.