Active not recruitingNAINTERVENTIONAL

Empagliflozin's Microcirculatory Effects in Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial

This study is investigating a new way to help people with a serious heart condition called cardiogenic shock. Despite current treatments, many patients don’t recover well. We know that problems with tiny blood vessels, called microcirculation, play a big role in this. A drug called empagliflozin has shown promise in heart failure, and we believe it might help these tiny blood vessels. This research will use special cameras to look at these tiny blood vessels in real-time before and after patients receive empagliflozin. By doing this, we hope to learn if empagliflozin improves blood flow in these vessels, which could improve patient outcomes and save lives.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital, Strasbourg, France

Enrolment target

Start

01 Jul 2025

Estimated completion

30 Sep 2027

Cardiogenic Shock

What is this study about?

When someone has cardiogenic shock, their heart can't pump enough blood to meet the body's needs. This is a very serious condition, and sadly, many people don't survive. Even with the best treatments we have today, about half of these patients still don't make it. This study is part of a larger effort to find better ways to help them.

Doctors used to think that only problems with the main, large blood vessels (like blood pressure) were important in cardiogenic shock. However, we now understand that issues with the tiny blood vessels, known as microcirculation, are also very important. These tiny vessels deliver oxygen and nutrients to every part of your body. When they're not working well, it can make the condition much worse. In fact, how well these tiny vessels are working can sometimes predict how a patient will do better than just looking at their blood pressure.

We're interested in a drug called empagliflozin. Previous studies have shown that it can help people with heart failure by protecting blood vessels. Because of this, doctors think empagliflozin might also help improve the microcirculation in patients with cardiogenic shock. This study will use special cameras to look at the tiny blood vessels under the tongue before and after patients receive empagliflozin. This will help us see if the drug helps these tiny vessels work better, which could lead to better recovery for patients.

Key takeaways

This study investigates a new treatment approach for serious heart conditions (cardiogenic shock).
It focuses on how empagliflozin affects tiny blood vessels (microcirculation).
We use special cameras to watch blood flow in these tiny vessels.
The aim is to see if empagliflozin improves blood flow and patient recovery.
Participation involves two short, non-invasive measurements over 48 hours.

Who may be eligible?

To be part of this study, you would first need to be taking part in the main EMPASHOCK study. You must be over 18 years old and be currently in intensive care for cardiogenic shock. You also need to have been receiving certain medications to help your heart for at least 12 hours. It's important that you are able to swallow tablets.

There are some reasons why you wouldn't be able to join. For example, if your kidneys aren't working well or if you are already on long-term kidney dialysis. You also can't join if you have a known allergy to empagliflozin or similar medications, or if you have specific types of diabetes (Type 1) or certain other heart conditions. If you are pregnant, breastfeeding, or a woman who could become pregnant and are not using contraception, you also would not be able to participate. This also applies to individuals under legal protection measures.

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 actively receiving care in an intensive care unit (ICU) for cardiogenic shock?
Are you at least 18 years old?
Have you been on heart support medicine for at least 12 hours?
Can you swallow tablets?
Do you have severe kidney problems or Type 1 diabetes?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the research team will first ask your family for consent, and then you directly if you get better. The study involves looking at your tiny blood vessels using a special video microscope placed gently under your tongue. This will happen twice.

The first time will be at the start of the study, before you receive the study medication (empagliflozin). The second time will be 48 hours later. At both times, we will also record your blood pressure and how much blood your heart is pumping. For patients who are not receiving empagliflozin, these measurements will still be taken at the same time points. The study focuses on these two measurement times and doesn't involve long-term follow-up beyond checking your survival status after 28 days.

Potential risks and benefits

There is a chance that empagliflozin could improve the blood flow in your tiny blood vessels, which might help your recovery, although this is what the study aims to find out and is not guaranteed. As with any medication, there can be side effects, which the medical team will discuss with you. The procedure to view your microcirculation is non-invasive and generally considered safe; however, specific risks will be explained by the study doctor. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Hôpitaux Universitaires de Strasbourg
Verified postcode
Strasbourg, France

Common questions

What is cardiogenic shock?

It's a very serious condition where your heart can't pump enough blood to meet your body's needs. It's life-threatening and requires urgent medical care.

What is empagliflozin?

It's a medication that has been shown to help people with heart failure. We're studying if it can also help people with cardiogenic shock by improving blood flow in tiny vessels.

What is microcirculation?

These are the body's smallest blood vessels, which deliver oxygen and nutrients to every part of your body. Poor microcirculation can be a problem in serious heart conditions.

How will you look at my tiny blood vessels?

We use a special video microscope that we gently place under your tongue. It takes pictures and videos of the tiny blood vessels there without causing discomfort.

Will I get empagliflozin in this study?

This study is part of a larger trial where some patients receive empagliflozin and others do not. Your doctors will explain which group you are in.