Less than 1% of UK children born with congenital heart disease are enrolled in clinical trials looking to improve treatments, according to research funded by the British Heart Foundation and led by the University of Birmingham, who reported on the study, and Birmingham Children’s Hospital.

The study, published in the European Journal of Cardio-Thoracic Surgery, is the first systematic review of its kind into clinical trials in children’s heart surgery.

The researchers analysed all three hundred and thirty three clinical trials published worldwide between January 1st 2000 and August 2016 on surgery for congenital heart disease, heart conditions that develop in the womb and the most common type of birth defect. They found only ten clinical trials (3%) were conducted in the UK in this time, none of which were phase III trials.

The researchers also found that only four hundred and thirty one out of the estimated sixty five thousand children who underwent heart surgery in the UK in this timeframe were enrolled in a clinical trial. In comparison, 70% of children suffering from cancer are enrolled in phase III clinical trials.

Although recent advances mean most children diagnosed with a congenital heart defect grow up to become adults, many face the prospect of multiple surgical operations, and sadly around four hundred children each year still die before they reach school age.

Poor recruitment was not able to explain the lack of clinical trials, with over 87% of trials able to recruit sufficient children. However, there are many different types of congenital heart diseases and it can be difficult for single hospitals to see enough of a particular type of the disease to carry out a meaningful trial.

Researchers suggest that one solution to this issue would be to establish a congenital heart disease research network which would allow researchers in all centres in the UK to collaborate and carry out research into the rarest types of congenital heart disease.

Lead author Nigel Drury, of the Institute of Cardiovascular Sciences at the University of Birmingham and consultant in paediatric cardiac surgery at Birmingham Children’s Hospital, said “The surgery available for children with heart problems has improved dramatically over the past twenty years. However, by not carrying out large-scale, cutting-edge clinical trials to continually improve surgeries, we’re letting down the thousands of children born in the UK each year with heart problems. As a congenital heart disease community, we have a responsibility to provide scientific leadership and work together to conduct well designed, rigorously conducted, multi-centre clinical trials to improve the outcomes of surgery for our patients and their families.”

The research is being highlighted as part of the BHF’s Christmas Appeal, which aims to raise £750,000 for life saving research towards congenital heart disease, which affects around four thousand UK children each year.

Professor Sir Nilesh Samani, Medical Director at the British Heart Foundation, said “For many children with congenital heart disease, the only treatment available is surgery. It can be a difficult choice for parents to agree to their child participating in research. However, the only way we can improve the range and quality of treatments for these children is through clinical trials. This study shows that we can and should do better if we are to improve the treatment and outcomes of children with congenital heart disease.”