IRAS ID: 1009448
ISRCTN: 13146458
Why is this research being done?
Mitral valve repair surgery is surgery that fixes the leakiness around one of the heart valves, the mitral valve. This leakiness allows blood to flow the wrong way (called mitral regurgitation), causing symptoms such as breathlessness and dizziness. After the mitral valve has been repaired there are certain risks of complications, such as blood clots and strokes. These risks are greater for those people who have an irregular heartbeat; a condition known as atrial fibrillation.
To try and prevent these complications, we traditionally give a blood thinning medication called warfarin. This is a type of drug called a vitamin K antagonist (VKA). However, using VKAs brings its own risks, including an increased risk of bleeding and bruising. It also requires closer monitoring, meaning more blood tests are needed.
There is another type of blood-thinning medication called a Direct Oral Anti-Coagulant (DOAC). This is a newer type of medicine and a lot of people are safely given these by their surgeons before and after heart surgery. DOACs also carry some risk of complications, such as bleeding.
Warfarin being an older type of medication is less expensive than DOACs, but the requirement for regular blood tests can increase the cost of using this. While DOACs cost slightly more as a drug, their use does not require regular clinic visits.
The AFFECT study will look at which of these two types of blood thinning medication works best in terms of reducing complications such as blood clots and strokes, and causes fewer additional complications such as bleeding. It will also look at the overall costs to the National Health Service (NHS) of using these drugs.
What happens to me if I agree to take part in this research?
If you agree to take part in this research study and your clinical team confirm you are eligible then you will be randomly allocated (randomised) to one of two groups by a computer – like the tossing of a coin. One group will receive a VKA (such as warfarin) and the other group will receive a DOAC (such as apixaban or edoxaban). There is an equal chance of being allocated to either group and you will be prescribed the medicine before you leave hospital.
Once you leave hospital, the research nurses will monitor your health for between 1 and 4 years. During this time, you will be contacted over the phone at 3 months, 12 months and then yearly thereafter to ask you about your health and to complete some questionnaires.
How many people will take part in this research?
1,282
At which hospitals will this study take place?
We aim to deliver this study across about 25 cardiac centres throughout the UK.
Current study centres are:
- The James Cook University Hospital, Middlesbrough
- Royal Sussex County Hospital, Brighton
Can I take part in this study?
We are looking for people over the age of 18 who have confirmed persistent or permanent atrial fibrillation (irregular heartbeat) who are planned to undergo a surgical repair of one of their heart valves (the mitral valve). There are additional criteria you would need to fulfil to be able to participate, so please speak to your usual care team about this.
How do I take part in this study?
In the first instance, speak to your usual care team or contact your closest hospital. They will be able to provide you with more detailed information and discuss with you what participation involves. You are also able to e-mail the central study team at [email protected]
Further information can be found in the patient information leaflet.
Who is organising and funding the study?
National Institute for Health and Care Research (NIHR), Health Technology Assessment (HTA) Programme grant funding is awarded to support the delivery of this trial (read more about the NIHR, who they are and what they fund on the NIHR website.
NIHR Grant Number: NIHR160252
The Academic Cardiovascular Unit at South Tees Hospitals NHS Foundation Trust is organising this study.
South Tees Hospitals NHS Foundation Trust is the ‘Sponsor’ of this study, meaning they are legally responsible.
The study has been submitted for favourable ethical opinion (ethical approval) by London – Harrow Research Ethics Committee.
Trial research team
Chief investigator
Professor Enoch Akowuah, consultant cardiothoracic surgeon, The James Cook University Hospital, Middlesbrough.
ACU team
- Mrs Sarah Kiddell, senior research project manager
- Dr Lisa Chang, principal research manager
- Ms Olivia Sawdon, research coordinator
Wider research team
- Rebecca Maier, head of the Academic Cardiovascular Unit at South Tees Hospitals NHS Foundation Trust.
- Mr Bilal Kirmani, consultant cardiothoracic surgeon, Liverpool Heart and Chest Hospital.
- Professor James Wason, professor of biostatistics, University of Newcastle upon Tyne.
- Professor Laura Ternent, professor of health economics, University of Newcastle upon Tyne.
- Ms Helen Mossop, senior research associate in statistics, University of Newcastle upon Tyne.
- Professor Laura Green, professor of haemostasis and transfusion medicine; consultant in haemostasis and transfusion medicine, Queen Mary University of London.
- Professor Gregory Lip, Price-Evans chair of cardiovascular medicine, director of Liverpool centre for cardiovascular science, University of Liverpool.
- Professor Julie Sanders, professor of cardiovascular care, King’s College London.
- Professor Scott Wilkes, head of the School of Medicine, professor of general practice and primary care, University of Sunderland.
- Mrs Sarah Murray, BHF CRC National PPI Group chair, patient and public involvement and engagement representative.
- Professor Gavin Murphy, professor of cardiac surgery and consultant cardiac surgeon, University of Leicester.
- Mr Narain Moorjani, consultant cardiothoracic surgeon, Royal Papworth Hospital.
- Dr Benoy Shah, consultant cardiologist, University Hospitals Southampton.
Current study status
Planned recruitment opening April 2025.
Planned study end date Friday 31 May 2030.