RecruitingPHASE2, PHASE3INTERVENTIONAL

Optimising Pacing for Contractility 2

This study, called 'Optimising Pacing for Contractility 2', is for people with heart failure who have a pacemaker. Researchers want to see if carefully tuning a pacemaker to a patient's 'best' heart rate can improve how well they can exercise and their overall quality of life. They've found that in the short term, this 'optimal' setting helped people walk longer on a treadmill. Now, they're expanding the study to 450 patients. Some will get the optimal setting, some the standard setting, and some no special changes. Over six months, the team will check if these improvements last, keep an eye on pacemaker battery life, and learn more about how these changes affect the heart.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

University of Leeds

Enrolment target

400

Start

01 Jun 2020

Estimated completion

31 Mar 2025

Heart Failure, Systolic Pacemaker

What is this study about?

In this study, researchers are exploring a new way to programme pacemakers for people living with heart failure. We know that heart failure can make it hard for your heart to pump blood effectively, which can lead to symptoms like breathlessness and tiredness. Pacemakers help regulate your heart rhythm, but this study is investigating if we can go a step further and optimise their settings to actually improve how strongly your heart muscle contracts. This is done by pinpointing an 'ideal' heart rate range for each individual.

The team has already seen promising results in smaller tests, where adjusting pacemakers to this optimal heart rate range led to people being able to exercise for about 60 seconds longer on a treadmill. This new, larger study aims to find out if these short-term benefits can last over a longer period – six months – and truly make a difference to people's daily lives and their ability to be active. The goal is to see if this personalised pacemaker setting can not only boost exercise capacity but also improve general well-being, all without negatively impacting the pacemaker's function or lifespan.

To do this, 450 participants with heart failure and a pacemaker will be part of the trial. They will be divided into three groups: one will receive the special 'optimal' pacemaker settings, another will have standard settings, and a third will have no specific rate adjustments. By comparing these groups, the researchers hope to gather strong evidence about the best way to use pacemakers to help people with heart failure feel better and live more active lives.

Key takeaways

Exploring if personalised pacemaker settings can improve heart failure.
Compares 'optimal' settings to standard or no changes over six months.
Aims to improve exercise ability and quality of life.
Involves heart scans, exercise tests, and questionnaires.
For people with heart failure who already have a pacemaker.
Participation involves 2 main visits and a phone call over 6 months.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with heart failure, which should be confirmed by your doctor, heart scans, and certain blood tests. You must also already have a pacemaker fitted.

It's important that you are able to do an exercise test, like walking on a treadmill, to help the researchers understand how your heart responds. You also need to be willing and able to understand the study information and provide your consent to take part.

However, you wouldn't be able to join if you experience chest pain (angina) that limits your ability to exercise, or if your heart failure symptoms have been unstable or your medications have changed recently (within the last three months). People whose heart scans aren't clear enough for accurate measurements, or who are taking a specific type of heart medication called calcium channel blockers, would also not be eligible.

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 I have a diagnosis of heart failure, confirmed by a doctor?
Do I already have a pacemaker implanted?
Am I able to safely walk on a treadmill for an exercise test?
Have my heart failure medications been stable for the last 3 months?
Am I not taking calcium channel blockers as medication for my heart?
Do I understand the study information and am happy to provide consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first receive a letter and information about the study, followed by a phone call to answer any questions. If you agree, you'll visit a special research clinic for your first appointment. This visit will involve signing a consent form, a routine check of your pacemaker, and a discussion about your health history.

Next, you'll have a heart ultrasound scan to help identify your 'optimal' heart rate range. You'll also do an exercise test on a treadmill, walking until you feel you can't continue, and fill out some questionnaires about your quality of life. You'll also be offered a chance to take part in additional, optional tests like advanced heart scans (MRI), blood tests, or tests looking at nerves that control heart function.

After this, you'll be randomly assigned to one of three groups for six months: either your pacemaker will be set to the 'optimal' settings, standard settings, or without any special rate adjustments. You'll get a follow-up phone call after one month to ensure you're comfortable with any changes. After six months, you'll repeat the initial treadmill test, ultrasound, and questionnaires to see if there have been any changes.

Potential risks and benefits

Taking part in this study could potentially improve your exercise capacity and quality of life by optimising your pacemaker's settings. However, there's no guarantee you'll personally benefit, as some participants will receive standard or no special adjustments. Risks are generally low, as pacemaker adjustments are routine, but as with any medical procedure, there's a small chance of unexpected side effects or discomfort during tests like the treadmill walk. You are free to withdraw from the study at any time without explaining why, and this will not affect your usual medical care.

Locations (1)

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

Leeds General Infirmary
Verified postcode
Leeds, United Kingdom· Recruiting

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 or breathlessness.

What is a pacemaker?

A pacemaker is a small device placed in your chest that helps control your heart's rhythm using electrical pulses.

What does 'optimal heart rate' mean in this study?

It's the specific heart rate range where your heart can pump blood most effectively for your condition.

How long will the study last for me?

After your initial assessment and pacemaker adjustment, you'll have a follow-up after one month and a final assessment at six months.

Will I know if I'm getting the 'optimal' setting?

No, this is a 'blinded' study, meaning neither you nor your doctors will know which setting you've received until after the study is complete, to keep the results fair.

How to find out more

Klaus K Witte, MD

k.k.witte@leeds.ac.uk 01133926642 Official trial record

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