RecruitingOBSERVATIONAL

Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE

This study aims to understand how to better identify and predict outcomes for adults admitted to hospital with serious heart failure, specifically a condition called cardiogenic shock. Researchers will look at information already collected during routine hospital care, alongside extra blood and urine samples. They hope to discover if details from examinations, scans, and blood tests, including differences between men and women, are linked to a patient's risk of death within 30 days. No new treatments are given in this study. It's about collecting existing information and samples to help doctors understand the condition better and improve patient care in the future.

At a glance

Status

Recruiting

Sponsor

University Heart Center Freiburg - Bad Krozingen

Enrolment target

600

Start

07 Aug 2024

Estimated completion

31 Jul 2028

Cardiogenic Shock Acute Heart Failure (AHF)

What is this study about?

Imagine your heart is a pump, and sometimes it doesn't pump enough blood to the rest of your body. This is called heart failure. If it's very severe and sudden, it's called acute heart failure, and sometimes it can lead to a really serious condition called cardiogenic shock, where your heart can't pump enough blood to keep your organs working properly. This study is trying to help doctors understand this serious condition better.

The main idea is to use information doctors already gather when you're in hospital – things like your symptoms, what they see on scans, and certain levels in your blood – to see if these clues can help tell apart different types of cardiogenic shock. By understanding these differences, doctors might be able to predict more accurately how someone might recover, or if they are at higher risk of problems, within the first month after being admitted to hospital. They are also looking to see if there are any differences between men and women in how this condition acts.

This is an "observational" study. This means you won't be given any new or experimental medicines, and your treatment will be exactly what your doctors think is best for you. The researchers are simply collecting and looking at information that's already being gathered as part of your normal hospital care, plus a few extra blood and urine samples. This helps them learn from what's already happening to improve care for future patients.

Key takeaways

This study helps doctors learn more about severe heart failure.
It uses existing patient information and a few extra samples, not new treatments.
The goal is to better understand and predict how patients recover.
Your normal medical care will not change.
Your participation could help improve care for future patients.

Who may be eligible?

This study is looking for adults who have been admitted to hospital because of serious, sudden heart failure that has led to a condition called cardiogenic shock. Doctors use a special scale (called SCAI stage B - E) to describe how severe the heart failure is, and only people within these stages can join.

You would not be able to join this study if you are unable to understand and agree to take part, unless that difficulty was unrelated to your heart condition. Also, if your cardiogenic shock developed after having heart or lung surgery, this study is not suitable for you.

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 an adult (18 years or older)?
Have you been admitted to hospital recently with severe, sudden heart failure and cardiogenic shock?
Can you understand and agree to take part in the study?
Did your cardiogenic shock *not* happen after heart or lung surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your participation will not involve any extra doctor's appointments or changes to your treatment. The study mainly involves researchers using information that is already being collected as part of your normal hospital care. This includes details from your medical records, examination findings, and results from your scans and routine blood tests.

Additionally, you will be asked to provide some extra blood and urine samples. These samples will be stored and used by the researchers to learn more about your condition. After you leave the hospital, the research team will continue to follow your progress by checking your medical records over time. This follow-up process continues for a certain period after you leave the hospital, but you won't need to make any extra visits or have any additional tests specifically for the study.

Potential risks and benefits

The main benefit of taking part is that the information and samples you provide could help doctors better understand acute heart failure and cardiogenic shock. This could lead to better ways of identifying different types of the condition and predicting how patients might recover in the future, ultimately improving care for others. As this is an observational study and you are not receiving any new treatments, there are no direct medical risks from participating beyond those associated with routine blood and urine sample collection, which are minimal. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (4)

University Heart Center Freiburg - Bad Krozingen
Verified postcode
Bad Krozingen, Germany· Recruiting
University Medical Center Freiburg, Interdisciplinary Medical Intensive Care
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
Department for Internal Medicine 8, Clinic for Cardiology and Rhythmology, University Clinic of the Paracelsus Medi-cal University Nuremberg
Verified postcode
Nuremberg, Germany· Active not recruiting
Schwarzwald Baar Klinikum Villingen-Schwenningen, Klinik für Kardiologie und Intensivmedizin
Verified postcode
Villingen-Schwenningen, Germany· Recruiting

Common questions

What is cardiogenic shock?

It's a serious condition where your heart can't pump enough blood to keep your body working properly, often as a complication of severe heart failure.

Will I get new medicine in this study?

No, this study does not involve any experimental treatments or new medicines. You will receive your usual medical care.

What happens with my blood and urine samples?

They will be collected and stored for researchers to study and learn more about your heart condition.

Will my personal data be kept private?

Yes, all your health information and samples will be handled confidentially and securely.

How long will I be in the study?

You'll be part of the study while in the hospital and they will follow your progress after you leave, using your medical records.

How to find out more

Lucas Bacmeister, MD

lucas.bacmeister@uniklinik-freiburg.de 004976127034010 Official trial record

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