Clinical trial NCT03871881: Impact of Congenital Heart Disease on Neurodevelopmental Outcome
Official title: The Impact of Congenital Heart Disease on Neurodevelopmental Outcome and Comorbidity in Adulthood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Defects, Congenital
Keywords: Magnetic resonance imaging
Brain
Neuropsychology
Heart Defects, Congenital
Follow-Up Studies
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2019-03-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are either adults who in childhood were diagnosed with an ASD or VSD, or healthy matched controls.

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.

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

Primary outcomes:
measure: Long-term impact of congenital heart disease on brain development
timeFrame: 12 months
Secondary outcomes:
measure: Long-term impact of congenital heart disease on neurocognitive outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Vibeke Hjortdal, MD, PhD
role: STUDY_CHAIR
References:
citation: Asschenfeldt B, Evald L, Salvig C, Heiberg J, Ostergaard L, Eskildsen SF, Hjortdal VE. Altered Cerebral Microstructure in Adults With Atrial Septal Defect and Ventricular Septal Defect Repaired in Childhood. J Am Heart Assoc. 2022 Jun 21;11(12):e020915. doi: 10.1161/JAHA.121.020915. Epub 2022 Jun 14.
citation: Lau-Jensen SH, Asschenfeldt B, Evald L, Hjortdal VE. Hyperactivity and Inattention in Young Patients Born With an Atrial Septal or Ventricular Septal Defect. Front Pediatr. 2021 Dec 6;9:786638. doi: 10.3389/fped.2021.786638. eCollection 2021.
citation: Asschenfeldt B, Evald L, Yun HJ, Heiberg J, Ostergaard L, Grant PE, Hjortdal VE, Im K, Eskildsen SF. Abnormal Left-Hemispheric Sulcal Patterns in Adults With Simple Congenital Heart Defects Repaired in Childhood. J Am Heart Assoc. 2021 Apr 6;10(7):e018580. doi: 10.1161/JAHA.120.018580. Epub 2021 Mar 22.
citation: Asschenfeldt B, Evald L, Heiberg J, Salvig C, Ostergaard L, Dalby RB, Eskildsen SF, Hjortdal VE. Neuropsychological Status and Structural Brain Imaging in Adults With Simple Congenital Heart Defects Closed in Childhood. J Am Heart Assoc. 2020 Jun 2;9(11):e015843. doi: 10.1161/JAHA.120.015843. Epub 2020 May 19.