Why are we doing the study?
CoQ10 helps to produce energy in the body, and some studies have shown that CoQ10 might be a helpful treatment for people with heart failure. However, more research is needed to be sure whether CoQ10 can help people with heart failure by improving how they feel, reducing the care that they need, and working out whether it is cost-effective for the NHS.
Who can take part?
You can take part in the CORAL study if you are over 18 years old, have a diagnosis of heart failure that affects your daily life AND your GP has said you might be eligible to take part.
You can only take part if you have received an invitation pack in the post from your GP surgery.
What is involved in taking part?
If you agree to take part, we will ask you to:
- Take 1 capsule 3 times a day for 12 months
- These will either be CoQ10, or a placebo, or ‘dummy’ capsule. Both capsules look the same, so you won’t know which you are taking until the end of the study. You can’t decide which one you get, and neither can your GP or the study team. This is so everyone gets a 50:50 chance of being in each group, so we can compare groups fairly.
- You might be asked to send back any capsules you haven’t used so we can count them, but we will tell you more about this if you are selected.
- Complete 5 questionnaires – once at the start of the study, then after 3, 6, 9, and 12 months
- The questionnaires take 20-30 minutes to complete, and will ask about things such as your symptoms, your health, and any care you receive.
- You can complete these on paper or online.
- We can give you a £10 gift voucher for every questionnaire you complete
All your other medical care will remain the same.
Do I have to take part?
No, you do not have to take part. Joining the study is entirely up to you. Your medical care will not change if you do not take part. If you do decide to take part, you are free to leave the study at any time, without giving a reason.
More about CoQ10
Coenzyme Q10, or CoQ10, is a nutrient that is found naturally in food such as meat, fish, and nuts. It can also be bought in health food shops and chemists as a health supplement. In this study, we are trying to find out whether taking CoQ10 three times a day for 12 months can improve quality of life in people who have heart failure.
If you decide to take part, you will be given either CoQ10 or placebo, or ‘dummy’ capsules. A process called “randomisation” (a bit like flipping a coin) will decide which group you go into. This will ensure that the results cannot be affected by anyone’s beliefs about CoQ10.
There are no known risks of taking CoQ10. However, there is a very small chance you might experience side effects from taking the capsules. Side effects are mild and stop when you stop taking the medication. They may include tummy problems, headache, dizziness, and skin reactions (e.g. rashes).
You, nor your GP will know which capsules you are taking, but in an emergency, we can quickly tell you which group you are in and whether you are taking CoQ10 or placebo. If you are unable to take the medication or you change your mind, you can stop taking the capsules and/or withdraw from the study at any time.
We will send you all of your capsules directly to you free of charge, through your letterbox. We might ask you to send back any capsules you haven’t used so we can count them, but we will tell you more about this if you are selected.
How long does the study last?
The study is expected to last between 2024 and 2027. No one will be able to identify you from any of the study reports or publications.
Click here to view the Participant Information Leaflets