Following the Fallot and Fontan/Single Ventricle Populations
Research type
Research Study
Full title
Following the Fallot and Fontan/Single Ventricle populations to discover biomarkers of complications.
IRAS ID
229551
Contact name
Louise Coats
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
1 in a 100 babies is born with a heart condition, some are minor and some are more complex. With improvements in surgery, almost all now survive to be adults. Many patients are well after these operations but others suffer complications. Two important groups are those with tetralogy of Fallot (who have two pumping chambers) and those with a Fontan operation (who have a single pumping chamber).
The challenge is to work out which patients are at risk of problems and to intervene before their hearts fail. We do not have proven markers to predict which patients will suffer complications. But, measurements are often suggested by different groups. For the clinical team to assess the value of these markers within our own population, ethical approval is required. If these markers are not tested they may become part of clinical practice, without evidence of usefulness. This is important, as patients become aware of such suggestions and wish to know if new findings can help them.
We wish, therefore, to perform an initial observational study to follow the clinical progress of these two groups. We wish to create an anonymised database to include clinical information about them, the tests they have and any complications that happen to them over time. We plan to follow them for five years. We have enough patients in our regional population to make meaningful analyses. We can recruit through Newcastle upon Tyne Hospitals NHS Foundation Trust and follow them with existing staff and resources. Conducting this as formal research is important to make sure we assess such tests before using them in clinical decision making.
REC name
Wales REC 7
REC reference
17/WA/0330
Date of REC Opinion
11 Oct 2017
REC opinion
Favourable Opinion