Impact of Congenital Heart Disease on Neurodevelopmental Outcome

University of Aarhus120 enrolled

Overview

The project aims toward clarifying the underlying mechanism and the long-term impact of congenital heart disease on neurodevelopment.

The project provides detailed information on the impact of congenital heart disease on neurodevelopmental outcome in adulthood. The study investigates if brain maturation and development, and the neurocognitive outcome is compromised in patients with atrial or ventricular septal defects more than 20 years after diagnosis and treatment. Data on brain morphology, brain tissue architecture, and resting-state function will be obtained by 3.0 Tesla MRI. Data on neurocognitive outcome will be obtained by a customized wide neuropsychological test battery. This study will clarify the extent of these patients' neurodevelopmental challenges and guide evaluate targeted interventions to alleviate potentially long-term effects.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Heart Defects, Congenital

Interventions

Magnetic Resonance ImagingOTHER

Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)

Neuropsychological assessmentOTHER

A special designed neuropsychological test battery of validated tests to assess function of cognitive domains

Eligibility

Sex: ALLMin age: 18 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * ICD codes DX Q21.0 (VSD) or DX Q21.1 (ASD), surgically repaired VSD or open ASD Exclusion Criteria: * lack of medical record, suffering from coronary artery disease or other congenital cardiac abnormalities, diagnosed syndromes, spontaneous closure of the atrial septum defect before inclusion-date, magnetic implants or non-MRI compatible foreign objects, pregnancy, lack of Danish language skills or suffering from severe lung disease

Locations (1)

Aarhus University Hospital

Aarhus N, Denmark

Outcomes

Primary Outcomes

Long-term impact of congenital heart disease on brain development

MRI analysis

Time frame: 12 months

Secondary Outcomes

Long-term impact of congenital heart disease on neurocognitive outcome

Neuropsychological assessment

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.