RecruitingNAINTERVENTIONAL

Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

When people get a pacemaker for the first time, doctors often use modern approaches to avoid damaging the heart. However, for those who already have an older, traditional pacemaker and later develop a weaker heart, these newer options aren't always considered. This study wants to find out if upgrading these patients to a more advanced, 'physiological' pacing system can make them feel better and improve their daily lives. We’re comparing the older and newer pacing methods to see which one leads to better symptoms and a higher quality of life for people whose hearts have become weakened by their current pacemaker.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

155

Start

25 Sep 2023

Estimated completion

31 Aug 2026

Pacing-Induced Cardiomyopathy Heart Failure

What is this study about?

Many patients have pacemakers to help their heart beat regularly. These devices are usually very helpful. However, sometimes, the way older pacemakers work can, over time, actually weaken the heart muscle, a condition called 'pacing-induced cardiomyopathy'. This can lead to symptoms like tiredness or breathlessness, similar to heart failure.

Modern pacemakers are designed to work in a way that’s more natural for the heart, aiming to prevent these problems. While doctors usually choose these modern pacemakers for new patients, those who already have an older pacemaker that might be causing heart weakness often don't get the option to upgrade, even when their battery needs changing. This study explores whether switching from an older, traditional pacemaker to one of these newer, more natural types can significantly improve how these patients feel and their overall quality of life.

We believe that by helping the heart beat in a more coordinated and natural way, a modern pacemaker might help patients feel less tired, less breathless, and generally improve their well-being. This research is important because it could change how doctors manage patients with pacemakers whose heart function has declined.

Key takeaways

This study explores a new pacemaker treatment for weaker hearts.
It compares older traditional pacing with newer, more natural methods.
We aim to improve patients' symptoms and daily lives.
Participants will have their pacemaker upgraded and its settings tested.
Your feedback on symptoms and well-being is vital.
Participation could improve heart health and quality of life.

Who may be eligible?

This study is looking for adults aged 18 or over. You might be suitable if you currently have a traditional pacemaker and your heart’s pumping ability has become a bit weaker, specifically between 35% and 50% of its normal strength. You also need to have your pacemaker regularly helping your heart beat a lot of the time (more than 40% of the time).

Additionally, your doctor must feel that you could benefit from a special procedure to upgrade your pacemaker. We'll also check if your heart function has dropped by a certain amount since your pacemaker was fitted, or if you have specific blood test results (NT-proBNP), changes in your heart's size, or are taking regular water tablets (diuretics). We'll also consider if you've noticed a decline in your daily activity or exercise tolerance, or if your pacemaker itself shows certain changes.

You cannot join if you are unable to understand and agree to take part, are under 18, or are pregnant.

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.

Do you have a pacemaker already planted?
Has your heart function become a bit weaker (between 35% and 50%)?
Does your pacemaker work more than 40% of the time?
Could your doctor recommend a pacemaker upgrade for you?
Are you 18 years old or older?
Are you NOT pregnant and able to agree to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have a procedure to upgrade your existing pacemaker to a new system that can deliver the modern pacing strategies. After this, there will be a one-month recovery period where your pacemaker will be set to work like your old one. Then, for the next two months, your pacemaker settings will be secretly changed every month between the older and newer ways of pacing. You won't know which setting you're on, and neither will your doctor for that period. This will be followed by two longer six-month periods, also secretly switching between the older and newer pacing types.

Throughout the study, you'll record your symptoms every month using a simple app on your phone or computer. At the end of each different pacing period (after the one-month recovery, and then after each of the one and six-month periods), you'll have some check-ups. These include tests to measure your heart's strength, a short walking test, and filling out questionnaires about your quality of life, including one called the SF-36. The total duration of your active participation, after the initial recovery, will be about 14 months.

Potential risks and benefits

Participating in this study might offer you the potential benefit of improving your heart function, symptoms, and overall quality of life by receiving a more modern pacing treatment. However, all medical procedures carry some risks, such as those associated with any pacemaker upgrade, like infection or bleeding. We will explain all potential risks in detail before you decide to join. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

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

Royal Papworth Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting
St. Richard's Hospital - University Hospitals Sussex
Verified postcode
Chichester, United Kingdom· Recruiting
University Hospitals Coventry and Warwickshire NHS Trust,
Verified postcode
Coventry, United Kingdom· Recruiting
Croydon University Hospital - Croydon Health Services
Verified postcode
Croydon, United Kingdom· Recruiting
Glenfield Hospital
Verified postcode
Leicester, United Kingdom· Recruiting
Hammersmith Hospital
Verified postcode
London, United Kingdom· Recruiting
King's College Hospital
Verified postcode
London, United Kingdom· Recruiting
St Bartholomew's Hospital - Barts Health NHS Trust
Verified postcode
London, United Kingdom· Recruiting
Oxford University Hospitals
Verified postcode
Oxford, United Kingdom· Recruiting
University Hospitals Southampton
Verified postcode
Southampton, United Kingdom· Recruiting
Great Western Hospitals
Verified postcode
Swindon, United Kingdom· Recruiting
Worthing Hospital - University Hospitals Sussex
Verified postcode
Worthing, United Kingdom· Recruiting

Common questions

What is 'physiological pacing'?

It's a newer way of pacing that tries to make your heart beat in a more natural, coordinated way, similar to how a healthy heart works.

Is a pacemaker upgrade a big operation?

It's a procedure to change some parts of your pacemaker system, usually less involved than getting a new pacemaker for the first time, but still requires a hospital visit.

How will you know if the new pacing is better?

We'll compare your symptoms, heart function tests, walking ability, and quality of life scores when you're on the older pacing versus the newer pacing settings.

Will I know which pacing setting I’m on?

No, for key parts of the study, neither you nor your doctors will know which pacing setting is active. This helps us get unbiased results.

What if my symptoms get worse during the study?

We will monitor you closely. If your symptoms worsen significantly, the study doctors will review your situation, and you can withdraw from the study at any time.

How to find out more

Aya Khalil

a.khalil@imperial.ac.uk 07749576830 Official trial record

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