Measuring Biomarkers in Children with Inherited Cardiovascular Disease
Research type
Research Study
Full title
Inherited Cardiovascular Diseases: The role of biomarkers in understanding paediatric disease pathophysiology and assessing their use for diagnostic and prognostic purposes
IRAS ID
185164
Contact name
Juan Pablo Kaski
Contact email
Sponsor organisation
Great Ormond Street for Children NHS Foundation Trust
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Inherited cardiovascular diseases (ICVDs; also known as inherited cardiac conditions, or ICCs) are diseases that run in families and lead to an increased risk of abnormal heart rhythms and sudden death. This study will collect blood and urine samples from children with or at risk of developing ICCs to see if we can identify markers that can be used to make a more accurate diagnosis and predict the progression of the disease.\nThe genetic basis of ICCs is well understood, but does not explain the reasons for the different clinical features of the diseases in different individuals. Studying children will give us the opportunity to look at ICCs at different stages in their disease progression (as children have often not fully developed the disease), allowing us to better identify patients at risk and target therapies more effectively. The ICC team at GOSH is the largest centre in Europe caring for children with ICCs and the research team have state-of-the-art equipment and expertise for this study.\nThe results of this study will be used to conduct further large-scale investigations to allow a better understanding of ICCs in children. In particular, we hope this will lead to new treatments for ICCs and allow us to identify more accurately children at high risk of sudden death so that this can be prevented. [COVID-19 amendment 20/07/2020]; In light of the current SARS-CoV-2 (Covid-19) pandemic, we are seeking a substantial amendment to this study in order to expand analysis of prospectively collected samples to include testing for COVID-19 antibodies and associated inflammatory biomarkers. By including data relating to Covid-19 in our existing study alongside our ongoing analysis of other biomarkers, we aim to better understand how the virus affects children diagnosed with an inherited cardiovascular disease and whether being diagnosed with one of these conditions puts patients at any increased risk from Covid-19. The proposed additional tests can be carried out using the same quantity of blood as collected previously, therefore this amendment does not require any additional samples to be collected. We expect this to be a temporary amendment to the study, lasting for twelve months.\nWe plan to report the result of Covid-19 antibody testing back to patients or their parents (if the patient is under 16 years old) and to the patient’s GP in writing. It will be made clear that tests are being carried out on a research basis and the clinical relevance of the results is therefore not currently clear, therefore patients should continue to follow government guidelines (on social distancing, hand hygiene, etc.) even in the event of a positive test result.\nWe have also amended previous spelling/wording errors and corrected some inconsistencies which were identified in the previous versions of the study paperwork.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/1888
Date of REC Opinion
10 Dec 2015
REC opinion
Further Information Favourable Opinion