All studies
RecruitingPhase IIIInterventional

Coenzyme Q10 for people with heart failure to improve their quality of life - the CORAL study

Heart failure can cause breathlessness, fatigue, and swollen legs, making everyday tasks difficult. Coenzyme Q10 (CoQ10) is a natural substance that helps our cells produce energy and protects them from damage. While it is sold in health shops, doctors do not yet know if it truly benefits people with heart failure. The CORAL study aims to find out. Adults with heart failure will be randomly chosen to take either CoQ10 or a matching dummy capsule (placebo) three times a day for one year. Neither the participants nor the research team will know who is taking which pill. Participants will fill in five short questionnaires from home over 12 months to track how they feel, earning a £10 voucher for each one completed. The study will help doctors decide if CoQ10 should be routinely prescribed on the NHS.

At a glance

Status
Recruiting
Phase
Phase III
Sponsor
University of Bristol
Enrolment target
950
Start
21 Feb 2025
Estimated completion
30 Nov 2026

What is this study about?

Heart failure is a long-term condition where the heart does not pump blood around the body as well as it should. It often causes symptoms such as breathlessness, severe tiredness, and swollen ankles or legs. These symptoms can make normal, daily activities like walking to the shops or climbing stairs feel exhausting and difficult.

Coenzyme Q10, often known as CoQ10, is an antioxidant nutrient that our bodies produce naturally to help cells generate energy and stay healthy. It is also widely sold over the counter as a food supplement. Early evidence suggests that giving extra CoQ10 to people with heart failure might help their heart muscle produce more energy, potentially easing symptoms and improving stamina. However, doctors need larger, reliable studies to know for certain whether it really works and offers good value for money.

The CORAL study is a UK-wide clinical trial run by the University of Bristol and funded by the National Institute for Health and Care Research (NIHR). It aims to discover whether adding CoQ10 to standard heart failure treatment gives people a better quality of life and reduces hospital visits. If the trial shows positive results, it could lead to new NHS guidelines recommending CoQ10 to help people manage their condition better.

Key takeaways

  • Tests whether the supplement CoQ10 can improve daily quality of life in heart failure.
  • Half of the participants take CoQ10 and half take a matching dummy pill for 12 months.
  • No hospital visits needed; all questionnaires are completed from home.
  • Participants receive a £10 voucher for each completed questionnaire.
  • People taking warfarin or with peanut/soy allergies cannot take part.

Who may be eligible?

You may be able to join the study if you are 18 or older and have a diagnosis of heart failure where the heart's main pumping chamber is weakened (sometimes called reduced ejection fraction). You should also experience daily symptoms such as breathlessness or fatigue when doing normal physical activities.

You cannot take part if you take the blood-thinning medicine warfarin, because CoQ10 can stop warfarin from working properly. You are also not eligible if you have taken CoQ10 supplements in the past six weeks, have an allergy to peanuts or soy, or are pregnant or breastfeeding.

In addition, the trial capsules are made using halal beef gelatine, so they may not be suitable if you follow a vegetarian, vegan, or strict plant-based diet. People currently taking part in another clinical trial testing a medication cannot join.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with heart failure with reduced pumping function.
  3. My heart failure causes symptoms like breathlessness or tiredness during normal daily tasks.
  4. I do not take the blood thinner warfarin.
  5. I have not taken CoQ10 supplements in the last six weeks.
  6. I do not have an allergy to soy or peanuts.
Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for 12 months. A computer will randomly place you into one of two groups: one group will take a CoQ10 capsule three times a day, and the other will take an identical-looking dummy capsule (placebo) three times a day. You do not need to attend extra hospital visits to participate. Instead, you will be asked to fill in five questionnaires from home over the year (one at the start and four follow-ups) to see how you are feeling and coping with daily life. You will receive a £10 voucher for every questionnaire you finish. The research team will also review your NHS medical notes to see if the treatment reduces GP visits or hospital stays.

Potential risks and benefits

You may not get any direct personal benefit from taking part, though if you receive CoQ10, you might notice an improvement in your symptoms and everyday energy. The study will also help doctors understand how to better treat heart failure in the future. CoQ10 is generally considered very safe, but mild side effects can occasionally occur, including an upset stomach, mild headache, dizziness, or a skin rash. Taking part is completely voluntary, and you can withdraw from the study at any time without giving a reason, which will not affect your standard NHS medical care in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Not provided at time of registration
    City only
    -, England

Common questions

Will I know if I am taking CoQ10 or the dummy pill?

No. To keep the test fair, both you and the researchers will not know which pill you are taking until the study has finished.

Should I carry on taking my usual heart medications?

Yes. The study capsules are meant to be taken alongside your regular heart medicines, not as a replacement for them.

Do I have to travel for hospital appointments?

No. The trial is designed to fit around your life. Questionnaires can be filled in from home, and your medication can be posted to you.

Why can't I join if I take warfarin?

CoQ10 can interact with warfarin and make it less effective at thinning your blood, which could put your health at risk.

Are the study capsules suitable for vegetarians?

No. The capsules are made using beef gelatine (halal certified), so they are not suitable for people who do not eat beef or animal products.

How to find out more

Barbara Warnes

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Coenzyme Q10 for people with heart failure to improve their …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.