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Clinical Trials/NCT03871881
NCT03871881
Unknown
Not Applicable

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

University of Aarhus1 site in 1 country120 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Defects, Congenital
Sponsor
University of Aarhus
Enrollment
120
Locations
1
Primary Endpoint
Long-term impact of congenital heart disease on brain development
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
August 1, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Benjamin Asschenfeldt Arlander, MD

Medical doctor, Principal investigator

University of Aarhus

Eligibility Criteria

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

Outcomes

Primary Outcomes

Long-term impact of congenital heart disease on brain development

Time Frame: 12 months

MRI analysis

Secondary Outcomes

  • Long-term impact of congenital heart disease on neurocognitive outcome(12 months)

Study Sites (1)

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