Who can take part?
The study is currently enrolling people diagnosed with hypertrophic cardiomyopathy aged between 18 and 65.
Who cannot take part?
You cannot take part if you suffer from uncontrolled hypertension, severe coronary artery disease, have had a previous heart attack, or if you have the following:
- permanent pacemaker or defibrillator
- metal clips in blood vessels of the brain
- injury to the eye involving fragments of metal
- shrapnel injuries
- other metal or electronic implants
or if you are pregnant or breast-feeding.
How do I prepare for the visit?
- You will be asked to avoid strenuous exercise for 24 hours before the visit. Strenuous exercise may interfere with the results of some of the blood tests.
- You will be asked to fast from midnight before your visit to us (i.e. eat normally the night before and avoid any breakfast on the morning of the scan). You will be allowed to eat after blood sample collection.
If you are unable to fast or forget, you can still take part in this study and we will still collect blood samples, but it is important that you tell us that you have eaten so we can note it down.
What happens during a visit?
During the visit, we carry out the following:
- Informed Consent. We will check if you are suitable for the study. If you are satisfied with the information we have provided and wish to take part, you will be asked to sign a consent form.
- Medical history and physical examination. We will ask some questions about your medical and family’s health history. We will also perform a simple physical examination e.g. blood pressure and heart rate.
- Electrocardiogram (ECG). If you have not had an ECG in the last 24 months, we will measure the electrical activity of your heart by attaching sticky pads to your chest.
- Echocardiogram. If you have not had an echocardiogram in the last 24 months, we will take a safe and painless picture of your heart using an ultrasound. Ultrasound waves then create images of your heart on the scanner monitor.
- Cannula and Blood Test. A cannula is a small tube which we will insert into the blood vessel (vein) in your arm using a needle to take blood samples.
- Cardiac Magnetic Resonance (CMR)
How often would I have to come for the tests and how long does it take?
- The study will involve one visit to the hospital. This visit will last about two hours (including short breaks)
- We would also like to have a follow-up telephone call with you on a yearly basis for up to 5 years to check your health (for example, we will ask if you have had any hospital admissions etc.).
What are the possible risks?
- As the scanner consists of a powerful magnet, it may attract certain metallic objects. You must not have a scan if you have had metallic objects or medical devices (e.g. pacemaker) inserted into your body during an operation.
- The scan involves lying flat in a slightly confined space and a small number of people find this too claustrophobic.
- If you are pregnant or breast-feeding, you should not take part because the MRI and gadolinium used in this study may harm an unborn or nursing baby.
- Gadolinium contrast dye is used for CMR and may occasionally cause headache, mild rash and very rarely a more severe allergic reaction. In people with healthy kidneys, gadolinium is removed from the bloodstream within a few hours. We will check your kidneys before we start if you are at risk of kidney disease and have not had your kidney function tested recently.
- Some people find the cannula (plastic tube) in the arm uncomfortable, and there can be bruising at the site of needle entry.
- In rare cases the ECG sticky pads can lead to skin irritation.
What are the possible benefits?
- You should not expect any direct benefits from taking part.
- Your help and the information we obtain from this study may improve our understanding of the heart’s structure and function in HCM and the possible risk of developing complications in the future. If successful, this will help guide doctors to find a better treatment for this condition.
- We may reimburse reasonable travel and parking expenses to and from the hospital (specific details for each site involved in this study are provided in the participant information leaflet).
- You will not receive any payments for participating in this study.