Not yet recruitingNAINTERVENTIONAL

Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

This research study is investigating a new way to support the heart in people who have severe heart failure, known as cardiogenic shock. This condition means your heart isn't pumping enough blood to your body. The treatment is called Synchronized Cardiac Support (SCS) and it works with a life-support machine called VA ECMO. During the study, researchers want to check if SCS is safe and effective in helping the heart recover. Specifically, they'll be looking to see if it helps reduce levels of a chemical called lactate in the blood, which is a sign of how well your body's organs are getting blood and oxygen. The SCS system is designed to work in time with your own heartbeat, to give your heart extra help when it needs it most.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Xenios AG

Enrolment target

Start

01 Sep 2025

Estimated completion

01 Sep 2026

Cardiogenic Shock Extracorporeal Membrane Oxygenation ECLS VA ECMO

What is this study about?

This study is about a serious heart condition called cardiogenic shock. This happens when your heart suddenly can't pump enough blood to meet your body's needs. It's a medical emergency that can be life-threatening. To help, doctors sometimes use a machine called VA ECMO, which takes over some of the work of your heart and lungs, providing oxygenated blood to your body.

This research is looking at a new way to use the VA ECMO machine, called Synchronized Cardiac Support (SCS). Imagine your heart beating: the SCS system is designed to work in sync with your heartbeat. When your heart is resting (between beats), the machine gives a boost of blood flow. When your heart is actively pumping, the machine helps by reducing its own flow slightly. This 'synchronized' approach aims to give your heart the optimal support and allow it to recover.

The main goal of this study is to find out if using this SCS treatment with the VA ECMO machine is safe and whether it effectively helps people with cardiogenic shock. A key indicator they'll be watching is blood 'lactate' levels. High lactate usually means your organs aren't getting enough oxygen. If SCS helps reduce lactate, it suggests the treatment is helping your body get better blood flow and your heart is improving. Understanding if this new approach works could lead to better ways of caring for people with this very serious condition.

Key takeaways

This study evaluates a new heart support system (SCS) for severe heart failure.
SCS works with a VA ECMO machine to help your heart pump blood.
The goal is to see if SCS is safe and helps improve heart function.
It aims to reduce 'lactate' levels, a sign of better blood flow to organs.
The treatment could last up to 14 days.
You have the right to leave the study at any point.

Who may be eligible?

To join this study, you must be at least 18 years old but generally no older than 85. You need to have cardiogenic shock, which means your heart isn't pumping enough blood, and doctors need to give you medicines to keep your blood pressure up. You also need to show signs that your body's organs aren't getting enough blood, such as cold skin or not passing much urine, and have a certain level of a chemical called lactate in your blood.

There are several reasons why someone might not be able to join. For example, if you are pregnant or breastfeeding, or if you've recently taken part in another clinical study. Also, if your cardiogenic shock was caused by certain mechanical problems in your heart, or if it's due to other conditions like a severe infection (sepsis) or significant blood loss, you wouldn't be eligible. They also can't include people with very high lactate levels, a high fever, or those who have certain blood clotting problems that mean they can't take blood-thinning medication.

Finally, if you had a cardiac arrest (when your heart stopped completely) outside of the hospital and it took a long time for it to restart, or if doctors don't believe your heart can recover (and you're not a candidate for a heart transplant), you would not be able to participate.

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 to 85 years old?
Do you have severe heart failure (cardiogenic shock)?
Are your organs showing signs of not getting enough blood (e.g., cold skin, low urine output)?
Do you not have a severe infection (sepsis) or a very high fever?
Have you not had certain types of previous heart damage or other non-heart related causes for your shock?
Can you take blood-thinning medication if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the Synchronized Cardiac Support (SCS) treatment as part of your care for cardiogenic shock, alongside standard treatments. This involves using the SCS system with the VA ECMO machine. The treatment can last for up to 14 days. During this time, your medical team will closely monitor your heart function and overall health. They will take regular blood samples, specifically to check your lactate levels, and perform other tests to see how you are responding to the treatment. You will be looked after in the hospital throughout the treatment period.

Potential risks and benefits

Participating in this study might offer a potential benefit by providing a new and potentially more effective way to support your heart during severe illness. However, the exact benefits are not yet fully known, as this is what the study aims to discover. As with any medical treatment, there are potential risks involved. The VA ECMO machine itself carries risks, and the SCS system is being tested for safety. Your doctors will explain all known risks associated with the treatment and the study procedures. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Krankenhaus Buchholz und Winsen gGmbH
Verified postcode
Buchholz, Germany
Elisabeth-Krankenhaus Essen GmbH
Verified postcode
Essen, Germany

Common questions

What is cardiogenic shock?

Cardiogenic shock is a severe condition where your heart suddenly can't pump enough blood to meet your body's needs, leading to very low blood pressure and organs not getting enough oxygen.

What is VA ECMO?

VA ECMO is a machine that acts like an artificial heart and lung, taking blood from your body, adding oxygen, and then pumping it back in, to help your actual heart and lungs rest and recover.

How does Synchronized Cardiac Support (SCS) work?

SCS is a special way of using the VA ECMO machine. It's designed to work in time with your own heartbeat, giving your heart extra support when it needs it, like an added boost between beats.

What is lactate and why are they measuring it?

Lactate is a chemical in your blood that usually goes up when your organs aren't getting enough oxygen. Measuring it helps doctors see if your body is getting enough blood flow and oxygen.

How long will the treatment last?

The Synchronized Cardiac Support treatment can last for up to 14 days, depending on your condition and how well you are responding.

How to find out more

Anja Derlet-Savoia, Dr.

anja.derlet@freseniusmedicalcare.com +49 6172 2686648 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.