About the study

 

 

Background and study aims
Heart failure is a long-term condition that causes difficulty breathing, tiredness and leg swelling, which can all impact daily life. Between 10 and 15% of people over the age of 75 have heart failure and it is responsible for around 5% of all emergency hospital admissions. Most people with heart failure have two or more long-term medical conditions and usually take a number of different medicines every day.

Coenzyme Q10 (CoQ10) is a nutrient that is available to buy in chemists and health food shops as a supplement. It is known to remove potentially damaging free radicals that can harm cells and also has an essential role in energy production. CoQ10 may improve how much energy and exercise people with heart failure can do, which in turn may improve their daily lives.

The CORAL study aims to find out whether taking CoQ10 for 12 months can improve quality of life in patients with a diagnosis of heart failure.

Who can participate?
Patients aged 18 years or over who have heart failure that impacts their daily lives.

What does the study involve?
Potential participants will be invited to take part in the study via a letter from their GP surgery. Half of the people in the study will be chosen at random (by a computer) to take a CoQ10 capsule three times a day for 12 months and half will have a placebo (a different capsule that looks exactly the same but doesn’t contain CoQ10) 3 times a day for 12 months. People in the study will not know which type of capsule they are taking.

We will ask participants to complete a questionnaire at the start of the study, and 4 more times over 12 months to record how they are feeling, and if they have taken time off work or needed any care. We will also request to look at the information that is normally recorded in medical notes about them, such as time in hospital and the cause, any referrals, emergency admissions or medications that are being taken.

What are the possible benefits and risks of participating?
Participants taking part might see an improvement in their quality of life. They will also receive a £10 voucher for every questionnaire completed. There are potential side effects, though these are rare and mild (tummy problems, headaches, dizziness, and skin reactions). Once the results of the study have been looked at, we will know if CoQ10 can benefit people with heart failure and should be recommended by doctors.

Who is funding this research?
The CORAL study is funded by the NIHR Health Technology Assessment (NIHR 152257). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health and Care Research (NIHR), or the Department of Health and Social Care (DHCS).