Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05979870 |
| Other study ID # |
277238 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
December 31, 2028 |
Study information
| Verified date |
August 2023 |
| Source |
Sahlgrenska University Hospital, Sweden |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this study is to investigate children with aortic and pulmonary valve disease
treated or untreated longitudinally. Established CMR measures with additional newly
developped, promising, highly refined and clinically applicable quantitative imaging
biomarkers, will be utilized as compared to the conventional CMR estimates.
The main question[s] it aims to answer are:
- [question 1]To evaluate risk stratification for surgery and intervention of the aortic-
and pulmonary valve
- [question 2]Investigate the cardiac and vascular hemodynamic and morphological changes
before and after interventional or surgical treatment of the aortic- and pulmonary valve
at short and long term.
Participants will undergo cardiac MRI before and after interventional or surgical treatment
of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control
group established at the department in another study.
Description:
Background:
An increasing number of children with complex congenital heart disease (CHD) are today
treated and survive into adulthood. They are in need of a lifelong surveillance for
cardiovascular complications and an individualised treatment.
In paediatric aortic and pulmonary valve disease, the long-term complications are related to
valvular dysfunction with myocardial fibrosis and ventricular dysfunction as a result of
longstanding volume or pressure overload. Many patients will need surgery or interventional
treatment already in childhood, where the optimal timing of the intervention is crucial,
since early treatment may prevent irreversible injury to the heart.
Moreover, to enable detection of recurrent or new problems early, a long-term diagnostic
follow-up is needed where cardiovascular magnetic resonance (CMR) has become important for a
serial reproducible assessment of morphology, function and recently advanced methods for flow
and tissue characterisation. Still the the clinical decision of the perfect time-point and
type of treatment for a child, may be difficult in many cases, and better measures are
needed.
Aim:
This project will investigate children with aortic and pulmonary valve disease treated or
untreated longitudinally using established CMR measures with additional newly developed,
promising, highly refined and clinically applicable quantitative imaging biomarkers, as
compared to the conventional CMR estimates. Investigators aim to evaluate risk stratification
and investigate the haemodynamic and morphological changes as well as physical capacity
before and after interventional or surgical treatment at short and long term.
CMR will be analysed for established imaging biomarkers as well as the potential value of new
data-driven computer tools searching for new information in the CMR images i.e. shape/texture
analysis of tissue change, regional haemodynamics, blood flow in relation to metallic
implants and evaluation of myocardial deformation over time.
CMR measures will be compared to data from echocardiography, catheterization and serological
markers.
Clinical importance:
If the new refined CMR biomarkers can reveal improved disease characterisation, they may
reveal feasible in aiding the clinical decision making to optimise timing of intervention and
predicting long term complications. This could contribute to individualise the treatment and
improve health in children with CHD. The study may lead to improved patient care and use of
socio-economical resources.
