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Impact of Congenital Heart Disease on Neurodevelopmental Outcome

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03871881
Enrollment
120
Registered
2019-03-12
Start date
2017-07-01
Completion date
2023-08-01
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Defects, Congenital

Keywords

Magnetic resonance imaging, Brain, Neuropsychology, Heart Defects, Congenital, Follow-Up Studies

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.

Interventions

OTHERMagnetic 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)

OTHERNeuropsychological assessment

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

Sponsors

Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Long-term impact of congenital heart disease on brain development12 monthsMRI analysis

Secondary

MeasureTime frameDescription
Long-term impact of congenital heart disease on neurocognitive outcome12 monthsNeuropsychological assessment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026