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Lack of Clinical Trials Pose Threat to Kids With Heart Disease

by Bidita Debnath on November 24, 2017 at 12:13 AM
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Lack of Clinical Trials Pose Threat to Kids With Heart Disease

A congenital heart defect is a problem with the structure of the heart. It is present at birth. Congenital heart defects are the most common type of birth defect.

Research funded by the British Heart Foundation and led by the University of Birmingham and Birmingham Children's Hospital has found that less than one percent of UK children born with congenital heart disease are enrolled in clinical trials looking to improve treatments.

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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 333 clinical trials published world-wide between 1st January 2000 and 31st 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 10 clinical trials (three percent) were conducted in the UK in this time, none of which were phase III trials - large, influential trials needed to change treatments or guidelines.
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The researchers also found that only 431 out of the estimated 65,000 (less than one percent) children who underwent heart surgery in the UK in this timeframe were enrolled in a clinical trial. In comparison, 70 per cent 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 400 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 percent 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 Mr 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 startling research is being highlighted as part of the BHF's Christmas Appeal, which aims to raise Ģ750,000 for life saving research towards congenital heart disease, which affects around 4,000 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."

Source: Eurekalert
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