Impact of Congenital Heart Disease on Neurodevelopmental Outcome

• Conditions: Heart Defects, Congenital
• Interventions: Other: Magnetic Resonance Imaging; Other: Neuropsychological assessment

• Registration Number: NCT03871881
• Lead Sponsor: University of Aarhus

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Status Verified: 2020-08
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-10
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• ICD codes DX Q21.0 (VSD) or DX Q21.1 (ASD), surgically repaired VSD or open ASD

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ventricular septal defect	Neuropsychological assessment	Patients who had surgical closure of a ventricular septal defect in childhood
Atrial septal defect	Magnetic Resonance Imaging	Patients with an open atrial septal defect, diagnosed in childhood
Healthy control	Neuropsychological assessment	Healthy, young adults matched on age, gender and education
Ventricular septal defect	Magnetic Resonance Imaging	Patients who had surgical closure of a ventricular septal defect in childhood
Atrial septal defect	Neuropsychological assessment	Patients with an open atrial septal defect, diagnosed in childhood
Healthy control	Magnetic Resonance Imaging	Healthy, young adults matched on age, gender and education

Primary Outcome Measures

Name	Time	Method
Long-term impact of congenital heart disease on brain development	12 months	MRI analysis

Secondary Outcome Measures

Name	Time	Method
Long-term impact of congenital heart disease on neurocognitive outcome	12 months	Neuropsychological assessment

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark