Enrolling by invitationNAINTERVENTIONAL

Pacing in Heart Failure With Preserved LVEF

This study is for people who have heart failure where the heart muscle pumps well, but the heart still struggles. It aims to see if a special type of pacemaker, called a CRT-pacemaker, can help. Ten volunteers from the University Hospital of Wales will have one of these pacemakers fitted. Over several visits, the researchers will test three different settings on the pacemaker. They want to find out if these different settings can improve the heart's ability to pump blood and reduce heart failure symptoms. This is a small, early-stage study to explore new ways to use an existing device.

At a glance

Status

Enrolling by invitation

Phase

Sponsor

Cardiff and Vale University Health Board

Enrolment target

Start

20 Jul 2023

Estimated completion

31 Mar 2025

Heart Failure

What is this study about?

You might have heard of pacemakers being used to help hearts beat regularly. This study is looking at a special type of pacemaker, called a CRT-pacemaker, to see if it can help people with a specific kind of heart failure. Normally with heart failure, the heart's main pumping chamber (the left ventricle) struggles to pump blood effectively. However, in this study, they are looking at people whose heart muscle pumps quite well, but they still have bothersome symptoms of heart failure.

Researchers believe that the way the heart's walls move can be important. They will be looking for a specific movement called 'septal flattening' during exercise. The study is trying to find out if a CRT-pacemaker, by helping the heart's walls move more efficiently, could improve how well the heart works even when the pumping action seems okay. This is a new way of thinking about how pacemakers could help in this type of heart failure.

The main goal is to understand if this approach is promising enough to do larger studies in the future. It's about exploring new potential treatments for heart failure that isn't helped by current usual care.

Key takeaways

This study evaluates different pacemaker settings for certain heart failure.
It aims to improve heart function and symptoms in people with heart failure.
Participation involves having a special pacemaker fitted.
Researchers will test three pacemaker settings during follow-up visits.
The study is a small, early-stage trial based in Wales.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to adults over 18 who have moderate to severe heart failure symptoms (meaning they get out of breath easily or struggle with daily activities), and these symptoms have been constant for at least three months. Importantly, their heart’s main pumping chamber should be working quite well, but they must show a specific heart movement called 'septal flattening' during an exercise test. All participants will also need to have tested negative for Covid before surgery and have had their final Covid vaccine dose at least two weeks beforehand.

However, some people will not be able to join. This includes anyone who can't give their permission to take part, or if they are already in another study. People with specific other heart problems, significant lung disease, severe kidney problems, or certain health conditions like uncontrolled diabetes or a history of blood clots, are also not eligible. If you've recently had heart surgery or a heart attack, or if you're pregnant or planning to get pregnant, you wouldn't be able to participate. There are also restrictions for people with a very high Body Mass Index (BMI over 35).

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 aged 18 or over?
Do you have moderate to severe heart failure symptoms, ongoing for at least 3 months?
Has your doctor told you that your heart's main pumping chamber (left ventricle) pumps quite well?
Have you been told you have 'septal flattening' during an exercise test?
Have you had your final Covid vaccine dose at least two weeks ago?
Are you not currently pregnant or planning to become so?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first have a thorough check-up to make sure it's safe for you to take part. This will include tests for Covid-19. Once accepted, you will have a CRT-pacemaker fitted during a surgical procedure, similar to how standard pacemakers are implanted. This is a common device and procedure. After the pacemaker is fitted, you will have three separate visits to the hospital. During these visits, the researchers will try out three different settings on your pacemaker, one setting per visit. There will be up to five days between each of these visits. The order in which they test the settings will be chosen randomly, like drawing lots. They will observe how you respond to each setting to gather information. The total duration of your active participation in the study will involve the implantation and these three follow-up visits.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study could be that one of the pacemaker settings might improve your heart failure symptoms, even though this is not guaranteed as it's an investigational study. There is also the benefit of contributing to medical science, which could help others with similar conditions in the future. The risks involve those associated with having a pacemaker fitted, such as infection, bruising, or complications from the surgery, although these are generally rare. You also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

University Hospital Wales
Verified postcode
Cardiff, United Kingdom

Common questions

What is heart failure with preserved LVEF?

It means your heart's main pumping chamber (left ventricle) still pumps blood quite well, but the heart muscle is stiff or doesn't relax properly, leading to symptoms like breathlessness.

What is a CRT-pacemaker?

It's a special type of pacemaker designed to coordinate the pumping action of different parts of your heart, aiming to make it pump more efficiently.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related care and devices are provided by the research team.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your normal medical care.

How many people are in this study?

This is a small pilot study involving 10 patients.

How to find out more

Official trial record

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