Prospective Evaluation Of Exercise-Induced Cardiac Conduction Instability In Predicting Ventricular Fibrillation Events In Hypertrophic Cardiomyopathy
This study aims to find a more accurate way to predict dangerous heart rhythms in people with an inherited heart condition called Hypertrophic Cardiomyopathy (HCM). While many people with HCM have no symptoms, a small number can experience life-threatening fast heartbeats. Currently, doctors decide who should have a life-saving implantable defibrillator (ICD) based on certain factors, but this isn't always perfect. This research is testing a new technique called 'Ventricular Conduction Stability' (V-CoS). This involves wearing a special vest that records your heart's electrical signals before and during exercise. The study will compare this new test with current risk assessment methods to see which is better at identifying individuals who would most benefit from an ICD.
At a glance
What is this study about?
Hypertrophic Cardiomyopathy (HCM) is a common inherited heart condition where the heart muscle becomes thickened. For many people, HCM doesn't cause any problems and they might not even know they have it. However, in a small number of people, this thickened muscle can sometimes lead to a dangerously fast and irregular heartbeat, which can be very serious and, in rare cases, lead to sudden death. While there's no cure for HCM, a device called an implantable cardioverter-defibrillator (ICD), similar to a pacemaker, can be surgically placed in a person's chest to deliver an electrical shock and stop these dangerous heart rhythms, potentially saving their life.
Deciding who needs an ICD is a really important decision. While an ICD can be life-saving, having one implanted can also come with its own challenges. Currently, doctors use certain guidelines and risk scores to work out who is most likely to experience these life-threatening heart rhythms and therefore benefit from an ICD. However, these methods aren't always perfect, and doctors are always looking for better ways to make these crucial decisions.
This study is exploring a new technique designed to improve how doctors predict these dangerous heart rhythms in people with HCM. This new method, called the 'Ventricular Conduction Stability' (V-CoS) test, involves wearing a special vest that picks up electrical signals from your heart while you are at rest and then while exercising on a treadmill. Researchers have already used this technique to look at heart abnormalities in people with HCM who have previously survived a life-threatening heart event. This project aims to compare the accuracy of this new V-CoS test against the existing methods to see which is better at identifying who is truly at highest risk and should therefore be considered for an ICD.
Key takeaways
- This study aims to improve how doctors predict dangerous heart rhythms in people with HCM.
- It compares a new test (V-CoS) involving a special vest and exercise with current risk assessment methods.
- Participation involves about half a day of testing, including a treadmill exercise and a low-dose CT scan.
- The study has no direct benefits for participants but could improve future patient care.
- You have the right to withdraw from the study at any time without affecting your medical care.
Who may be eligible?
You might be able to take part in this study if you're an adult aged 18 to 100 years old and have a confirmed diagnosis of Hypertrophic Cardiomyopathy (HCM). Generally, for HCM, this means your heart muscle is thicker than usual (for example, 15mm or more), or if your heart muscle is slightly less thick (over 13mm) but you also have a close relative with HCM and other signs of heart changes.
Crucially, you would need to be considered at either intermediate or high risk of having a dangerously fast heartbeat in the next five years, based on your current medical assessment by doctors specialising in inherited heart conditions at a London clinic or another participating hospital.
However, you wouldn't be able to join the study if you've had a previous cardiac arrest (your heart stopped) or a life-threatening fast heartbeat that needed urgent medical help. You're also excluded if you have other specific health conditions that cause heart thickening, such as very high blood pressure or certain rare genetic conditions. If you already have an ICD that has previously delivered a shock because of a dangerous heart rhythm, or if you can't safely stop taking certain heart medications (beta-blockers) for the test, or if you have severe movement limitations preventing exercise, you wouldn't be able to participate. Pregnant individuals, or those planning pregnancy at the time of the CT scan, and anyone with skin allergies to ECG gel would also not be suitable for the study.
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 between 18 and 100 years old?
- Do you have a confirmed diagnosis of Hypertrophic Cardiomyopathy (HCM)?
- Are you considered by your doctor to be at intermediate or high risk of sudden cardiac death from HCM?
- Do you have no history of previous cardiac arrest or a life-threatening fast heartbeat needing urgent medical help?
- Can you safely do light exercise on a treadmill?
What does participation involve?
If you decide to join the study, you'll first have a chat with the research team at your clinic to make sure you understand everything and give your permission. You can ask any questions you have during this time. Your decision to join or leave the study won't affect how your doctors care for you.
The main part of the study involves spending about half a day at a hospital unit that specialises in heart tests. During this half-day, you'll:
1. Have any last questions answered and confirm your permission to participate. 2. Have a special vest, which looks like a waistcoat, put on. This vest has sensors that attach to your skin with a conductive gel to record your heart's electrical activity. 3. Undergo a quick, low-dose CT scan of your chest. This scan helps to accurately map your heart's position relative to the sensors on the vest. The radiation exposure is very small, similar to what you'd naturally get over about six months. 4. Walk or run on a treadmill while wearing the vest. The vest will record your heart's electrical signals during this exercise. 5. Repeat the V-CoS test while performing a 'Valsalva manoeuvre'. What this means is you’ll be asked to try and breathe out forcefully, as if you're blowing up a balloon, but without actually letting air out of your mouth or nose.
If you have a pacemaker or defibrillator already implanted, there might be an additional test where your device is used to create extra heartbeats while the vest records the signals. The study will involve a follow-up period of up to 5 years, during which your doctors will continue to monitor your health. The total duration of active patient participation would be the half-day testing, plus regular follow-up to monitor your health over 5 years.
Potential risks and benefits
Locations (1)
- Imperial College Healthcare NHS TrustVerified postcodeLondon, United Kingdom
Common questions
What is Hypertrophic Cardiomyopathy (HCM)?
HCM is an inherited heart condition where the heart muscle is thicker than normal. Most people with HCM live normal lives, but some are at risk of dangerous fast heart rhythms.
What is an ICD?
An ICD (Implantable Cardioverter-Defibrillator) is a small device, like a pacemaker, surgically placed in the chest. It can deliver an electrical shock to correct dangerous fast heartbeats and save lives.
What is the V-CoS test?
V-CoS is a new test being studied. It involves wearing a special vest that records your heart's electrical activity while you are at rest and exercising on a treadmill, to look for signs of unstable heart rhythms.
Will I have to stop my usual heart medication?
The study mentions that you should be safe to discontinue beta-blocker medications if you are on them, as this might be required for the test. This would be discussed with you by the medical team.
How long will I be involved in the study?
The main testing day at the hospital will take about half a day. After that, your health will be followed up for up to 5 years as part of the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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