Not yet recruitingNAINTERVENTIONAL

Remote Monitoring and Optimization of Heart Failure Therapy

Heart failure means your heart doesn't pump blood as well as it should, leading to symptoms like breathlessness. After being in hospital for heart failure, people are often at higher risk of getting worse or needing to go back to hospital. This study is testing if a wearable device, called the Heart Failure Management System (HFMS), can help improve care for these patients. Some patients will get standard care, while others will also use the HFMS device, which tracks things like heart rate and breathing. Medical teams check this information to spot any early signs of problems. The aim is to see if this extra monitoring can lead to better health outcomes and fewer hospital visits over a year.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Zoll Medical Corporation

Enrolment target

800

Start

01 Oct 2026

Estimated completion

01 Aug 2029

Heart Failure

What is this study about?

Heart failure is a condition where your heart struggles to pump enough blood around your body. This can make you feel tired, short of breath, or cause fluid to build up in your legs or lungs. When people have been in hospital because their heart failure symptoms got worse, they are often at a higher risk of needing to go back to hospital or experiencing further problems.

This study was set up to investigate if a new approach could help these patients. It focuses on a special wearable device, called the Heart Failure Management System (HFMS). This device continuously collects information from your body, such as your heart rate, how you're breathing, how active you are, and if your body is holding onto too much fluid. The medical team then reviews this information. The idea is that by monitoring these signs closely, they might be able to spot early warning signs that your heart failure is getting worse, allowing them to adjust your treatment sooner rather than later.

By helping doctors act quickly, the study hopes to find out if using this device can lead to better health for people with heart failure. This could mean fewer emergency visits, fewer hospital stays, and a better quality of life overall. The study will compare patients who use the device alongside their usual care with those who only receive usual care, to see if the device makes a real difference.

Key takeaways

Tests a wearable device for heart failure patients after hospital stays.
Aims to improve care by early detection of worsening symptoms.
Compares device users with those receiving standard care.
Follow-up for up to one year to check health outcomes.
Focuses on reducing hospital visits and improving quality of life.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and willing to follow the study's instructions. You must have recently left the hospital after being admitted for acute heart failure, which means your symptoms, like severe breathlessness or fluid in your lungs, suddenly got worse. We would also need to check that your blood pressure, heart rate, and certain blood test results are stable enough.

There are also specific criteria regarding any heart failure medications you were taking before your recent hospital admission. This helps make sure we are studying people who might benefit most from the new monitoring approach.

However, some conditions might mean you can't join the study. For example, if you are under 18, have severe lung disease that significantly affects your breathing, have had heart surgery recently, or if your heart failure was caused by another problem that can be easily fixed, like a severe irregular heartbeat, you wouldn't be able to participate. Also, if you have known intolerances to high doses of certain heart medications, that would exclude 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 18 years old or older?
Have you recently been in hospital because your heart failure symptoms got worse?
Are you able and willing to follow study instructions?
Do you have stable blood pressure and heart rate (checked by a doctor)?
Do you not have severe lung disease or other major conditions that would interfere with the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly placed into one of two groups, like flipping a coin. You'll either receive your usual medical care, or you'll receive your usual medical care plus the wearable Heart Failure Management System (HFMS) device. If you're in the device group, you'll wear the HFMS device for 90 days. This device collects information continuously, which your care team will review.

Regardless of which group you're in, you'll be followed for up to one year. During this time, the study team will collect information about your health, including any hospital visits, emergency room trips, changes in your heart failure, and how your quality of life is. There will be regular check-ups or ways for the study team to collect this important information, which will be discussed fully with you before you agree to take part. There are no direct visits mentioned beyond standard care, but data collection will be ongoing.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as closer monitoring of your heart failure if you are in the device group, which could lead to earlier detection of worsening symptoms and potentially swifter adjustments to your treatment. This could help prevent future hospitalizations. However, there's no guarantee that you will personally benefit from joining. As with any medical study, there are potential risks, though these are generally low for wearing a monitoring device. These might include skin irritation from the device or the inconvenience of wearing it. All possible risks will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

CHU Nancy
Verified postcode
Nancy, France
Justus-Liebig University Giessen
Verified postcode
Giessen, Germany
Policlinico Casilino
Verified postcode
Roma, Italy
UMC Utrecht
Verified postcode
Utrecht, Netherlands
PIM MSWiA Hospital
Verified postcode
Warsaw, Poland
Hospital Universitario 12 de Octubre
Verified postcode
Madrid, Spain
Uppsala University Hospital
Verified postcode
Uppsala, Sweden
University Zurich
Verified postcode
Zurich, Switzerland
Southampton University Hospital NHS Foundation Trust
Verified postcode
Southampton, United Kingdom

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as effectively as it should, making everyday activities harder due to symptoms like tiredness and breathlessness.

What is the HFMS device?

It's a wearable device that continuously monitors your vital signs like heart rate, breathing, and activity, helping your medical team keep a closer eye on your heart health.

Will I have to wear the device forever?

No, if you are in the group using the device, you will wear it for 90 days as part of the study.

How long will the study last for me?

You will be followed by the study team for up to one year, gathering important information about your health during that time.

Will my usual heart failure treatment change?

You will continue to receive your standard medical care, and the device is used in addition to that, not instead of it, to help guide management.

How to find out more

Manon Lemaire, Master

mlemaire@zoll.com +33 (0)6 33 57 18 52 Official trial record

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