Improving Care for Children With Congenital Heart Disease.

Launched by LUND UNIVERSITY HOSPITAL · Dec 11, 2020

Keywords

ClinConnect Summary

This Swedish study from Lund University Hospital is exploring whether blood-based cardiovascular biomarkers, along with non-invasive heart imaging, can improve screening for congenital heart disease (CHD) in infants and children and help predict if and when a child might need heart surgery or a catheter-based procedure. It’s a non-randomized, case-control study that compares children with predefined CHD lesions (before any intervention) to healthy children with no CHD. Participants will have blood tests and non-invasive heart tests such as ECGs, echocardiography, and, for some, MRI. The study keeps the biomarker results and advanced imaging findings blinded to the participants and their care teams to avoid bias.

Key details for eligibility: children aged 0-17 years living in participating regions of Sweden, whose guardians consent to take part; healthy controls must have no CHD or cardiovascular disease, and cases must have predefined CHD lesions before any corrective surgery or catheter intervention. Enrollment began in 2020 and is ongoing, with an estimated 98 participants. The main goal is to see how long after diagnosis a child might need open-heart surgery or a catheter intervention within three years. Secondary goals include testing newborn screening using circulating biomarkers, profiling biomarker levels over time, and using advanced imaging to measure heart function as kinetic energy, all to improve risk assessment and treatment decisions. The study is led by Lund University Hospital with partners in Jönköping and Gothenburg, and results may be shared in anonymized form after the study ends.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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