Investigating Complications in Repaired Congenital Heart Disease
Research type
Research Study
Full title
Investigating Complications in Repaired Congenital Heart Disease - A Pilot Study of Novel Biomarkers
IRAS ID
212342
Contact name
Louise Coats
Contact email
Sponsor organisation
Newcastle Joint Research Office
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Research Summary
Due to the success of surgery in childhood, there is a growing population of adults with repaired congenital heart disease. Problems later in life are frequent, particularly in more complex patients who have reduced life expectancy compared to the general population. The commonest cause of complications and early death is failure of the heart or the circulation. The causes of this are poorly understood and differ from heart failure that develops as a result of a heart attack or heart muscle problem. There are few effective medical treatments available and for many heart transplant may be the only option.
This study is a pilot that begins to address the important question of who will develop heart failure later on. The challenge being to identify the failing circulation prior to decompensation and to find therapies that can change progression before irreversible effects are established.
This study involves two groups of patients with repaired congenital heart disease (tetralogy of Fallot and Fontan) and a group of liver patients who will act as a control. It will be carried out in the clinical outpatient setting and is expected to take 18 months to complete. This study aims to assess the practicality of collecting and measuring relevant urine and blood biomarkers (measurable substances in the body whose presence may indicate the disease state) alongside relevant non-invasive imaging assessments of the state of the circulation in these patients. This study will determine the feasibility, variability within the individual and potential utility of these measurements in a small cohort of patients and will go on to inform design of further larger multi-centre studies that will investigate the causes, mechanisms and possible therapeutic interventions for heart and circulation failure in these patient groups.Summary of Results
Hearts with only one pumping chamber are repaired by a series of operations that lead to one side of the circulation being supported by the pumping heart and blood flowing passively on the other side (lung side). In some patients, this eventually is associated with heart failure and multiple organ dysfunction.
In this study we tested for suggested blood markers and imaging measurements that might suggest the circulation was failing. This was a pilot study and so did not have enough numbers to determine differences with comparison groups. We demonstrated success in recruitment, feasibility in the methods and were able to generate data related to the measurements used which can be used to deign further studies.REC name
HSC REC B
REC reference
17/NI/0247
Date of REC Opinion
5 Dec 2017
REC opinion
Favourable Opinion