RESPONDER-HF Trial
The RESPONDER-HF trial is looking at a new treatment for a specific type of heart failure often called 'heart failure with preserved ejection fraction' (HFpEF). In this condition, the heart pumps out a normal amount of blood, but it's stiff and doesn't relax properly to fill with enough blood. This can cause breathlessness and tiredness. The study is testing a small device called an 'atrial shunt.' This device is like a tiny tunnel placed between the upper chambers of your heart. The idea is to reduce pressure in the left side of the heart, which might make it easier for your heart to work and improve your symptoms. Researchers want to see if this shunt can help people feel better and improve their overall health over 5 years.
At a glance
What is this study about?
The RESPONDER-HF study is all about finding new ways to help people living with a particular type of heart failure. You may have heard of heart failure where the heart struggles to pump blood effectively; this is often called 'heart failure with reduced ejection fraction.' However, there's another common type, called 'heart failure with preserved ejection fraction' (HFpEF). With HFpEF, your heart can still pump blood out with good force, but the problem is that it's become stiff and doesn't relax enough to fill properly with blood. This means your body might not get as much blood as it needs, especially when you're active, leading to symptoms like shortness of breath and extreme tiredness.
Currently, there aren't many specific treatments for HFpEF, so doctors are keen to find new options. This study is testing a device called an 'atrial shunt' (specifically, the Corvia Atrial Shunt System or IASD System II). Think of this shunt as creating a tiny, controlled opening between the two upper chambers of your heart. The aim is to relieve pressure in the left upper chamber, which can get too high because the heart isn't filling properly. By reducing this pressure, doctors hope it will make it easier for your heart to work, reduce symptoms, and ultimately improve your quality of life.
To make sure the results are fair and accurate, half the patients in the study will receive the active device, while the other half will have a similar procedure but without the device being implanted, acting as a 'control' group. This helps researchers understand whether any improvements are truly due to the device or other factors. Both groups will be carefully monitored for five years to see how they are doing. This long-term follow-up is important to understand the full impact of the treatment.
Key takeaways
- Tests a new device (atrial shunt) for a specific type of heart failure (HFpEF).
- Aims to relieve heart pressure to improve symptoms and quality of life.
- Compares the device to a similar procedure without implantation (control group).
- Requires a minor procedure and careful follow-up over five years.
- Participation is voluntary; you can withdraw at any time.
- Suitable for people aged 40+ with symptomatic HFpEF.
Who may be eligible?
This study is for adults, aged 40 or older, who have a specific type of heart failure known as 'heart failure with preserved ejection fraction' (HFpEF). This means your heart's main pumping chamber (left ventricle) still pumps blood effectively (40% or more), but the heart muscle itself is stiff and doesn't relax well to fill with enough blood. You should be experiencing ongoing symptoms that limit your daily activities, even with your current heart failure medications.
You would have had at least one hospital stay for heart failure, or needed stronger diuretic (water tablet) treatment in the last year, or have certain blood test results that indicate heart stress. It's also important that your current heart failure treatment has been stable for at least a month.
Doctors will do some special tests, including an exercise test while you're lying down, and some heart scans (echocardiograms) to measure pressures and how well your heart is relaxing and filling, to confirm if you meet all the criteria for this study. These tests help ensure that the study is right for you and that the researchers can accurately assess the device's effects.
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 40 years old or older?
- Have you been diagnosed with heart failure where your heart still pumps well, but is stiff (HFpEF)?
- Have you had heart failure symptoms that affect your daily life and needed recent treatment (like diuretics or a hospital stay)?
- Are you currently on stable heart medication for at least one month?
- Are you able to do some light exercise, like riding a bike lying down?
What does participation involve?
If you join the study, you'll first have some special tests, including an exercise test while lying down, to check if you're suitable. Once confirmed, you'll be randomly assigned to either receive the atrial shunt device or have a similar procedure without the device. You won't know which group you're in (nor will your doctors initially), to ensure the results are fair.
Both groups will have a minor procedure where a thin tube is inserted into a vein in your leg. If you're getting the device, it will be guided into place using X-rays and special ultrasound scans of your heart. If you're in the control group, you'll have similar scans of your heart without the device being implanted.
After the procedure, you'll have regular follow-up appointments over five years. These appointments will involve check-ups, scans, and possibly more exercise tests to monitor your heart health and symptoms. All your medications will continue as prescribed by your doctor. You and your doctors will find out which group you were in after 24 months of follow-up.
Potential risks and benefits
Locations (61)
- Arizona Cardiovascular Research CenterVerified postcodePhoenix, United States
- Scripps ClinicVerified postcodeLa Jolla, United States
- MemorialCare Long Beach Medical CenterVerified postcodeLong Beach, United States
- Christiana Care Health ServicesVerified postcodeNewark, United States
- Memorial Regional HospitalVerified postcodeHollywood, United States
- NCH NaplesVerified postcodeNaples, United States
- Cleveland Clinic FloridaVerified postcodeWeston, United States
- Northside Hospital Gwinnett CampusVerified postcodeLawrenceville, United States
- Wellstar KennestoneVerified postcodeMarietta, United States
- Northwestern UniversityVerified postcodeChicago, United States
- University of Chicago Medical CenterVerified postcodeChicago, United States
- Endeavor Health-NorthshoreVerified postcodeGlenview, United States
Common questions
What is 'heart failure with preserved ejection fraction' (HFpEF)?
It's a type of heart failure where your heart muscle is stiff, making it hard to relax and fill properly with blood, even though it still pumps blood effectively.
What is an 'atrial shunt'?
It's a small device that creates a tiny opening between the upper chambers of your heart to help relieve pressure, aiming to improve your heart's function.
Will I know if I'm getting the device or not?
No, initially neither you nor your doctors will know which group you are in. This is to ensure the study results are unbiased. You'll find out after two years.
How long will I be followed in the study?
You will be followed and have regular check-ups for a total of five years to see the long-term effects of the treatment or comparison.
Can I stop participating in the study if I change my mind?
Yes, you can choose to leave the study at any time, and this will not affect the medical care you receive for your heart condition.
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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