The effectiveness and cost effectiveness of coenzyme Q10 in heart failure with reduced
ejection fraction: a pragmatic, patient-centred, data-enabled trial in primary care (CORAL)

 

Funding

National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Ref. NIHR152257.

What is the problem?

Heart failure means the heart can’t pump blood properly either because it is too weak or too stiff. People with heart failure often feel short of breath and tired. Their feet and ankles swell up. These symptoms can lead to poor quality of life.

People with heart failure and their health professionals say that research to understand what can improve quality of life is most important to them. Heart failure is diagnosed using a scan of the heart (an echocardiogram). This measures the “ejection fraction”– the amount of blood that is squeezed out of the main pumping chamber of the heart with every heartbeat. Some people with heart failure have a normal ejection fraction, but this research focuses on people with heart failure with a reduced ejection fraction.

What is the aim of the research?

The main aim of the study is to find out if coenzyme Q10 improves quality of life. Coenzyme Q10 is a vitamin-like substance that occurs naturally in the body and in some foods. We want to conduct a study to find out if taking coenzyme Q10 is beneficial for people with heart failure and reduced ejection fraction.

How will this be achieved?

We will find this out by asking people who are taking part to fill out questionnaires. The questionnaires will ask about their quality of life and day to day life (the Kansas City Cardiomyopathy Questionnaire, EuroQol 5 Dimensions
of health questionnaire, and the New York Heart Association questionnaire).

There will also be a questionnaire asking how heart failure affects them and their carers financially. People taking part in the study will be asked to fill in these questionnaires before the study starts, then at 3, 6, 9 months and one year (when the study ends). We think the questionnaires will take about 35 minutes to fill in and we will compensate people £10 for their time for each set of questionnaires.

With permission, we will use their medical record to find out about healthcare appointments, hospital admissions and survival. To make it easy for people with heart failure to take part in the study, we will not be asking them to attend their hospital or GP practice for any study visits. They will be sent information about the study by post, their GP or nurse will phone them up to explain the study and their study medication will be sent directly to their house. People taking part in the study will have several options for completing their questionnaires: online, by telephone or face-to-face in their GP practice.

Who is leading the research?

Dr Maria Pufulete, Senior Research Fellow, University of Bristol and Dr Rachel Johnson, Associate Professor in Primary Care, University of Bristol.

Further information:

For more information or to get involved in this project, please contact bnssg.research@nhs.net.

The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.