Status:
ENROLLING_BY_INVITATION
Improving Care for Children With Congenital Heart Disease.
Lead Sponsor:
Lund University Hospital
Collaborating Sponsors:
Region Jönköping County
Göteborg University
Conditions:
Heart Disease Congenital
Ventricular Septal Defect
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
Establish a cardiovascular biomarker profile to help screening for congenital heart disease in infants and children as well as use non-invasive cardiac imaging in combination with such profiling to be...
Detailed Description
Analysing circulating cardiovascular biomarkers using blood samples should improve identification of congenital heart disease in newborns, in particular for those needing future cardiac interventions....
Eligibility Criteria
Inclusion
- obtained written informed consent prior to enrolment
- resident within participating healthcare regions in Sweden during study
- age 0-17 years at enrolment
- Controls: No evidence of congenital heart disease and no history of cardiovascular disease
- Cases: congenital heart lesions prior to open heart surgery or cardiac catheter intervention with grouping into i.e. ventricular septal defects and atrial septal defects, complex and critical cases requiring infant surgery or patency of the arterial duct to maintain the circulation postnatally.
Exclusion
- inability to obtain written informed consent prior to study enrolment and/or comply with study protocol
- non-resident in participating healthcare regions of Sweden during study
- age more than 17 years at enrolment
- presence of congenital heart disease where the lesion has already been treated by open heart surgery or cardiac catheter intervention
- participation in other research study with conflicting aims / interests
Key Trial Info
Start Date :
February 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04667455
Start Date
February 17 2020
End Date
October 1 2025
Last Update
March 4 2025
Active Locations (1)
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1
Children's Heart Centre at Lund's University Hospital
Lund, Skåne County, Sweden, 221 85