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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mark
Danton
mark.danton@glasgow.ac.uk
Mark
Danton
mark.danton@glasgow.ac.uk
Mark
Danton
mark.danton@glasgow.ac.uk
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Tetralogy of Fallot (TOF) is a common congenital heart malformation comprising a defect of ventricular septation with
underdevelopment of the right ventricular outflow. TOF is surgically corrected in infancy with typically excellent mid to
long-term outcomes. However, late morbidity related to right ventricle (RV) dysfunction comprising heart failure,
arrhythmia and death, may occur in adulthood which accrues with increasing age. The causation of RV dysfunction
relates to various mechanisms including myocardial injury/scarring related to previous surgery, abnormal RV
pressure/volume loading related to Pulmonary valve dysfunction, and conduction abnormalities. Prosthetic
pulmonary valve replacement (PVR) has been strongly promoted to reduce pulmonary regurgitation and remodel the
RV in the hope to improve clinical outcomes. However, the indications and timing of PVR, currently based on
symptomatology, increased RV volumes and reduced function, have been insufficient to consistently improve patient
outcomes.
Computational heart models have the potential to investigate RV mechanics of TOF and predict the ventricular
response of PVR intervention. This study proposes an interdisciplinary collaboration between clinicians, imaging
specialists and applied mathematicians with the aim to establish a high-fidelity computational simulated cardiac
model for TOF based on patient MRI data. Subsequently, the patient-specific model will be used to characterise RV
mechanics in clinically stable TOF, and TOF patients pre and post-PVR. A comparison will be made with healthy
age/gender-matched controls. We propose that personalized cardiac models will identify relevant RV biomarkers that
can potentially predict the benefit, or otherwise, of PVR in patients with TOF. RV mechanics and their relationship to
patient well-being will be determined by cardiopulmonary exercise testing and clinical follow-up. Adult patients with
repaired TOF will be invited to recruit including those under consideration, or who have had PVR. This research has
transferable potential to inform other heart diseases in which RV failure is a principal determinant of the outcome.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Case-controlled study;
You can take part if:
You may not be able to take part if:
Patients who are unable, or unwilling to provide informed consent for the study, including deceased patients Patients without suitable MRI or CPET data.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mark
Danton
mark.danton@glasgow.ac.uk
Mark
Danton
mark.danton@glasgow.ac.uk
Mark
Danton
mark.danton@glasgow.ac.uk
The study is sponsored by NHS NATIONAL WAITING TIMES CENTRE BOARD and funded by BRITISH HEART FOUNDATION .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 55565
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
