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NCT03871881 Clinical Trial

Impact of Congenital Heart Disease on Neurodevelopmental Outcome

Heart Defects, Congenital Clinical Trial

Official title:
The Impact of Congenital Heart Disease on Neurodevelopmental Outcome and Comorbidity in Adulthood

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03871881
Other study ID # Brain&CHD
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date August 1, 2023

Study information
Verified date August 2020
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 120
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 42 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Magnetic Resonance Imaging
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 assessment
A special designed neuropsychological test battery of validated tests to assess function of cognitive domains

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus N

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term impact of congenital heart disease on brain development MRI analysis 12 months
Secondary Long-term impact of congenital heart disease on neurocognitive outcome Neuropsychological assessment 12 months
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