Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes
This research is testing a new way to help people with heart failure. It involves a small wireless sensor, called CardioMEMS™, which is gently placed into an artery in your lung. This sensor measures the pressure in your lungs, which can be an early sign that your heart failure is getting worse. Doctors and nurses can then use this information to adjust your medication or care plan quickly, aiming to keep you feeling better and reduce your chances of needing to go to the hospital. The study will compare how well people do with this sensor treatment compared to standard care, focusing on their health, safety, and quality of life over 12 months.
At a glance
What is this study about?
Heart failure is a condition where your heart can't pump blood around your body as effectively as it should. This can lead to symptoms like shortness of breath and tiredness. Sometimes, when your heart failure isn't well controlled, fluid can build up in your lungs, causing pressure to rise. Catching these pressure changes early could help your medical team adjust your treatment before you become very unwell and need to go to hospital.
This study is investigating a new device called the CardioMEMS™ HF sensor. It's a tiny, wireless sensor that would be placed in one of your lung arteries during a minor procedure. Once implanted, the sensor can continuously measure the pressure in your pulmonary artery. This information is then sent to your healthcare team, who can monitor it from a distance.
The idea is that by having this detailed, up-to-date information, your doctors and nurses can make more informed and timely decisions about your heart failure medication and treatment plan. The study wants to see if this close monitoring and personalized care can help people with heart failure stay healthier, improve their quality of life, and reduce the number of times they need to be admitted to hospital for their heart condition. Participants will be followed for 12 months, and data on long-term health will also be collected.
Key takeaways
- This study tests a new sensor for heart failure management.
- The sensor helps doctors adjust treatment based on lung pressure.
- Aims to improve health and reduce hospital stays for heart failure.
- Involves a 12-month follow-up period.
- Participants either get the sensor or standard heart failure care.
Who may be eligible?
To join this study, you need to be at least 18 years old. You should have been experiencing heart failure symptoms that have limited your daily activities (often called NYHA Stage III) for most of the last month, and you must have been admitted to hospital due to your heart failure at least once in the past year.
You also need to be able to take certain blood-thinning medications for a month after the sensor is put in. If your heart has a reduced pumping ability (reduced LVEF), you should already be on guideline-recommended heart failure medications. If your heart's pumping ability is normal (preserved LVEF), then other health conditions you have should be well-managed according to guidelines.
There are also some reasons why you might not be able to join. For example, if you're already in another medical study that involves an active treatment, or if you've had a serious heart event like a heart attack, open-heart surgery, or a stroke in the last two months. Also, if your heart failure is very severe and not responding to treatments, or if you have plans for major new heart treatments in the next year, you might not be suitable.
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 or older?
- Have your heart failure symptoms limited your activity for most of the last month?
- Have you been in hospital for heart failure in the last year?
- Can you take blood-thinning medication for one month?
- Are you able to attend follow-up appointments?
What does participation involve?
If you agree to take part, you'll first need to give your written consent after having all your questions answered. You'll either receive the CardioMEMS™ sensor or continue with standard heart failure care. If you receive the sensor, it will be implanted during a minor procedure.
For all participants, basic care involves regular phone contact with a healthcare centre and your GP to make sure your treatment is optimized. If you have the sensor, specially trained staff will monitor your lung pressure readings. Based on these readings, your therapy might be adjusted. You'll be followed for 12 months to see how well the treatment is working. At the end of the study, information about your long-term health will also be gathered.
Potential risks and benefits
Locations (36)
- SLK-Kliniken GmbH - Klinikum am PlattenwaldCity onlyBad Friedrichshall, Germany
- Kerckhoff-Klinik Forschungs GmbHVerified postcodeBad Nauheim, Germany
- Herz- und Diabeteszentrum NRWVerified postcodeBad Oeynhausen, Germany
- BG Unfallkrankenhaus BerlinVerified postcodeBerlin, Germany
- Charité Universitätsmedizin (Campus Mitte, Campus Virchow, Campus Benjamin Franklin)Verified postcodeBerlin, Germany
- DHZC, Campus VirchowVerified postcodeBerlin, Germany
- Praxis am SpreebogenVerified postcodeBerlin, Germany
- Sana Klinikum LichtenbergVerified postcodeBerlin, Germany
- Klinikum BielefeldVerified postcodeBielefeld, Germany
- Universitätsklinikum BonnVerified postcodeBonn, Germany
- Klinikum CoburgVerified postcodeCoburg, Germany
- St Johannes Hospital DortmundVerified postcodeDortmund, Germany
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood as well as it should, leading to symptoms like tiredness and breathlessness.
What is the CardioMEMS™ sensor?
It's a tiny, wireless device placed in your lung artery to measure pressure, helping doctors track your heart failure.
Will I have an operation for this sensor?
Yes, the sensor is put in during a minor procedure, similar to a standard heart catheterisation.
How long will I be in the study?
You will be followed for 12 months to see the effects of the treatment, with additional long-term health data collected.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, and your regular medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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