James Cook Hospital leads national heart drug trial

The study, known as the AFFECT trial, is funded by the National Institute for Health and Care Research (NIHR) and launched by the Academic Cardiovascular Unit (ACU) at The James Cook University Hospital in Middlesbrough.

It aims to determine the safest and most effective blood-thinning medication for patients with heart rhythm problems following heart valve surgery.

Professor Enoch Akowuah, chief investigator for the AFFECT trial at University Hospitals Tees, said: “This is an important question for both patients and clinicians.

“We know anticoagulation is essential for patients with atrial fibrillation after mitral valve repair, but we do not yet know which treatment offers the best balance of safety and protection.

“The AFFECT Trial will provide high-quality evidence to guide national treatment decisions and improve long-term outcomes for patients across the UK and internationally.”

Each year, thousands of people in the UK undergo surgery for mitral regurgitation, a condition where the mitral valve does not close properly, causing blood to flow backward into the left atrium.

This places extra strain on the heart and can result in fatigue, breathlessness, and eventually heart failure.

Patients with additional heart rhythm disorders typically require blood-thinning medication to reduce the risk of stroke and other complications after surgery.

Current clinical guidelines recommend a vitamin K antagonist (VKA) such as warfarin, though direct oral anticoagulants (DOACs) are now also widely used.

The trial will compare these options to identify which offers the best long-term results.

The study aims to enrol 1,282 adults undergoing mitral valve repair at cardiothoracic centres nationwide.

Participants will be randomly assigned to receive either a DOAC or a VKA, starting before discharge, with patients then being closely monitored for at least 12 months, with further annual check-ups for up to four years.

Researchers will evaluate stroke prevention, quality of life, and cost-effectiveness.

More than 130 patients have already enrolled and begun treatment.

Eligible patients are approached for participation by their clinical teams.