Active not recruitingNAINTERVENTIONAL

Electromechanically Optimised Right Ventricular Pacing In Hypertrophic Cardiomyopathy (EMORI-HCM)

The EMORI-HCM study is for people with a heart condition called Hypertrophic Cardiomyopathy (HCM), where the heart muscle is unusually thick, making it hard for blood to flow. Many current treatments aren't ideal, so we're exploring another option: using pacemakers. If you already have a pacemaker or are due to get one (often combined with an ICD, a device that can give a small electric shock for dangerous heart rhythms), you might be able to help. We want to see if carefully adjusting pacemaker settings can relieve the blockage in the heart and improve symptoms like shortness of breath and chest pain, making daily life better. This study will involve finding the best pacemaker settings for you and then observing their effects over several months in a carefully organised trial where neither you nor your doctor will know if the special settings are on or off.

At a glance

Status

Active not recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

14 Mar 2022

Estimated completion

16 May 2025

Hypertrophic Cardiomyopathy Hypertrophic Obstructive Cardiomyopathy

What is this study about?

Hypertrophic Cardiomyopathy (HCM) is a common heart condition where the heart muscle becomes thicker than it should be. This extra thickness, especially in an area called the left ventricular outflow tract (LVOT), can block the flow of blood leaving your heart. This blockage can make you feel very tired, breathless, have chest pain, or even faint. Current treatments, often with medicines, don't always work perfectly for everyone or can have side effects.

Many people with HCM already have a device called an Implantable Cardioverter Defibrillator (ICD) fitted. An ICD is primarily there to protect you from serious, fast heart rhythms by giving a controlled electric shock if needed. However, these devices can also work as pacemakers, which help regulate your heartbeat. The exciting part is that pacemakers might be able to help with HCM by changing how the heart muscle squeezes, which could reduce the blockage and make it easier for your blood to flow. This study wants to find out if using these pacemaker features can make a real difference to your symptoms and how you feel day-to-day.

Our research aims to find the best way to use these pacemaker functions. We'll be looking at different aspects, such as the best place to put the pacing wire in the heart (if you're having a new device fitted) and how to fine-tune the timing settings of the pacemaker. We will use careful measurements to see how these adjustments affect the blood flow in your heart and your blood pressure. The main goal is to improve your symptoms and quality of life by finding the most effective pacemaker settings.

Key takeaways

Exploring if pacemakers can significantly improve HCM symptoms.
Aimed at people who have an ICD/pacemaker or will soon get one.
Will involve fine-tuning pacemaker settings for best results.
A 6-month study to see the impact of these settings on symptoms and quality of life.
You won't know if the special settings are on or off during the main trial period.

Who may be eligible?

This study is looking for adults aged 18 to 100 years old who have been diagnosed with Hypertrophic Cardiomyopathy (HCM). To be considered, your heart scan (echo) needs to show a certain level of blockage (at least 30 mmHg) from the thickened heart muscle, whether at rest or when provoked. You also need to be experiencing symptoms related to your HCM.

Crucially, you must either be scheduled to have a dual-chamber pacemaker or an ICD (which also acts as a pacemaker) fitted soon, or already have one of these devices implanted. You also need to be willing to take part and able to understand and sign the consent form.

You won't be able to join the study if you are under 18 or over 100, are pregnant, or have certain other heart rhythm problems like persistent Atrial Fibrillation or high-grade Atrio-Ventricular Block. You also can't take part if you are unable to give consent.

Quick self-check

Do I have a diagnosis of Hypertrophic Cardiomyopathy (HCM)?
Do I experience symptoms from my HCM?
Am I either getting a pacemaker/ICD soon or do I already have one?
Am I aged between 18 and 100 years old?
Am I able to understand information and give consent to take part?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it will involve some initial assessments to find the best pacemaker settings for you. If you're having a new device fitted, doctors will temporarily try different positions for the pacing wire in your heart and measure how this affects your heart's blood flow and blood pressure using special equipment like an ultrasound scan (echo) and a blood pressure monitor. For both new and existing device owners, fine-tuning of your pacemaker's timing (called AV delay) will be done to find the optimal setting for your heart.

After these initial checks, you'll take part in the main study, which lasts for 6 months. For an initial 3-month period, you will have your optimal pacemaker settings turned on. Then, you will return, and the settings will be adjusted, so for the next 3 months, these optimal settings will be turned off. This is a crossover study, meaning everyone gets both periods, and it's 'double-blinded,' so neither you nor the doctors assessing you will know if the optimal settings are on or off during these 3-month periods. You will visit the clinic at the start, at 3 months, and again at 6 months for assessments, which will include questions about your symptoms and quality of life.

Potential risks and benefits

Taking part in this study could potentially offer benefits such as improved symptoms like breathlessness, chest pain, and a better quality of life if the optimal pacemaker settings are found to be effective for you. However, there's no guarantee you will personally benefit. For those having a new device, there's a temporary additional procedure during the implant to test different pacing wire positions, which carries a small additional risk, though care will be taken to minimise this. All medical procedures carry some risks, and the study team will discuss these with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

National Heart & Lung Institute, Imperial College London
London, United Kingdom

Common questions

What is Hypertrophic Cardiomyopathy (HCM)?

HCM is a heart condition where your heart muscle becomes unusually thick, which can sometimes block blood flow and cause symptoms like breathlessness.

What is an ICD?

An ICD is a small device implanted in your chest that can deliver an electric shock if your heart beats dangerously fast. It can also act as a pacemaker.

What does 'pacemaker optimisation' mean?

It means carefully adjusting the settings of your pacemaker to find the most effective way for it to help your heart pump blood better and reduce your symptoms.

What does 'double-blinded' mean in a study?

It means that during the study, neither you nor your doctor will know whether the special pacemaker settings are switched 'on' or 'off' at any given time. This helps make the study results more reliable.

How long will I be in the study?

The main part of the study is 6 months, with an initial assessment period before that. You'll have visits at the start, at 3 months, and at 6 months.