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Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR

This study, called WE-CARE-HF-CMR, is happening in major cities across Germany. It's looking for people aged 40 to 69 who have risk factors for heart failure, like diabetes or high blood pressure, but don't yet have any symptoms. The main goal is to find out how common this hidden (unrecognized) heart failure is in these cities and to find better ways to screen for it early. Researchers will use mobile MRI scanners, along with questionnaires and blood tests, to check people. The information gathered will help create a new screening method and will be compared to a similar study done in rural areas, helping us understand differences between city and country populations.

At a glance

Status
Recruiting
Sponsor
German Heart Institute
Enrolment target
600
Start
13 Sep 2025
Estimated completion
31 Dec 2036

What is this study about?

Imagine your heart as a pump that sends blood around your body. Sometimes, this pump can become less efficient, even if you don't feel sick right away. This is called heart failure. Doctors have noticed that heart failure is often missed until it's more advanced, especially in people who are at risk but don't have symptoms yet.

This study, called WE-CARE-HF-CMR, wants to fix that. It's looking for a better way to find early signs of heart problems in people aged 40 to 69 who live in big cities in Germany and have certain health conditions that put them at risk. Things like having diabetes, high blood pressure, or being overweight can increase your risk. The study aims to figure out how common these early, unrecognized heart problems are.

To do this, the study uses special mobile MRI (Magnetic Resonance Imaging) scanners that come to different clinics in these cities. This makes it easier for people to take part. Researchers will also ask questions about your health and take blood samples. By gathering all this information, they hope to create a new way to check for heart failure early, helping doctors offer support sooner. The results will also be compared to a similar study done in rural areas of Germany, which will give us a clearer picture of how heart health might differ in city versus country settings.

Key takeaways

  • The study helps find hidden heart problems in people at risk.
  • It uses mobile MRI scans, blood tests, and questionnaires.
  • It's for people aged 40-69 in big German cities.
  • No new medicines or long-term follow-up are involved.
  • Results will help create better early detection methods for heart failure.

Who may be eligible?

This study is looking for volunteers between the ages of 40 and 69. You can be male, female, or another gender. The most important thing is that you should not currently have symptoms of heart failure and should not have been diagnosed with it before. You also need to be able to understand the study information and agree to take part.

To be eligible, you also need to have at least one of these health conditions: diabetes, kidney problems, high blood pressure, high cholesterol, obesity (a BMI over 30), or a history of smoking. These conditions are what the researchers call 'risk factors' for developing heart failure.

However, there are reasons you might not be able to join. These include having a pacemaker, certain metal implants (like clips in your brain), or other things that make MRI scans unsafe. If you have severe claustrophobia (fear of confined spaces), significant hearing loss, acute mental health issues needing treatment, are pregnant, or have very low blood pressure or heart rate, you also 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.

  1. Are you between 40 and 69 years old?
  2. Do you have diabetes, high blood pressure, high cholesterol, kidney problems, obesity, or a history of smoking?
  3. Have you *not* been diagnosed with heart failure before?
  4. Do you *not* have a pacemaker or other metal implants that make MRI scans unsafe?
  5. Are you able to agree to take part in the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step will be to connect with the study team through a video call in a dedicated room or a special vehicle. During this call, the researchers will explain the study in detail and get your consent to participate, all done remotely following legal guidelines.

Your participation will involve one main visit to a mobile MRI diagnostic unit, which is a large truck, set up at various clinic locations in major German cities. During this visit, you will have a special heart MRI scan. This MRI is designed to be comfortable – it doesn't use needles, doesn't require you to be stressed (like on a treadmill), and doesn't use a dye called contrast agent. You will also fill out a questionnaire about your health and quality of life, and have some blood tests taken. All these procedures will be carried out by staff from the company operating the MRI units, under the remote supervision of the study doctors. The study aims to collect this information in one session, and there aren't any medicines involved or long-term follow-up visits planned for this specific study.

Potential risks and benefits

Taking part in this study could offer you a benefit by potentially detecting early signs of heart problems you weren't aware of, allowing you to discuss these findings with your doctor. You would also be contributing valuable information that could help improve early detection methods for heart failure for many other people in the future. The main risks involve the standard considerations for an MRI scan, such as claustrophobia, although the scan is designed to be as straightforward as possible. You might also experience minor discomfort from blood tests. There is no stress testing or contrast dye used. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Deutsches Herzzentrum der Charité
    Verified postcode
    Berlin, Germany· Recruiting

Common questions

What is 'unrecognized heart failure'?

It means you have early signs of heart failure that haven't caused symptoms yet, so you or your doctor aren't aware of it.

Why are only people with diabetes or high blood pressure included?

These conditions increase your risk of heart failure, so the study focuses on people who are more likely to develop it.

What is a mobile MRI unit?

It's an MRI scanner built inside a large truck, making it easier to bring the scanning equipment to different places.

Will I get any medicine as part of the study?

No, this study is about checking for heart problems, not giving new medicines. You'll continue your usual treatments.

Is the MRI safe if I have metal in my body?

The study has strict rules. If you have things like a pacemaker or certain metal implants, you won't be able to have an MRI due to safety reasons.

How to find out more

Prof. Dr. Sebastian Kelle

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

Interested in taking part?

Register your interest

Share your details and the research team for "Determination of the Prevalence of Unrecognized Heart Failur…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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