NCT03871881

Impact of Congenital Heart Disease on Neurodevelopmental Outcome

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Defects, Congenital

Interventions

Type	Name	Description
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)
OTHER	Neuropsychological assessment	A special designed neuropsychological test battery of validated tests to assess function of cognitive domains

Timeline

• Start date: 2017-07-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2019-03-12
• Last updated: 2021-05-10

Locations

1 site across 1 country: Denmark