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Impact of Congenital Heart Disease on Neurodevelopmental Outcome

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ClinicalTrials.gov Identifier: NCT03871881
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Benjamin Asschenfeldt Arlander, MD, University of Aarhus

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

Condition or disease Intervention/treatment
Heart Defects, Congenital Other: Magnetic Resonance Imaging Other: Neuropsychological assessment

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Impact of Congenital Heart Disease on Neurodevelopmental Outcome and Comorbidity in Adulthood
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atrial septal defect
Patients with an open atrial septal defect, diagnosed in childhood
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

Ventricular septal defect
Patients who had surgical closure of a ventricular septal defect in childhood
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

Healthy control
Healthy, young adults matched on age, gender and education
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




Primary Outcome Measures :
  1. Long-term impact of congenital heart disease on brain development [ Time Frame: 12 months ]
    MRI analysis


Secondary Outcome Measures :
  1. Long-term impact of congenital heart disease on neurocognitive outcome [ Time Frame: 12 months ]
    Neuropsychological assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871881


Contacts
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Contact: Benjamin Asschenfeldt, MD +4578453081 ba@clin.au.dk
Contact: Vibeke Hjortdal, MD, PhD vhjortdal@clin.au.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Benjamin Asschenfeldt, MD    +4578453081    ba@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Study Chair: Vibeke Hjortdal, MD, PhD University of Aarhus

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Responsible Party: Benjamin Asschenfeldt Arlander, MD, Medical doctor, Principal investigator, University of Aarhus
ClinicalTrials.gov Identifier: NCT03871881     History of Changes
Other Study ID Numbers: Brain&CHD
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Asschenfeldt Arlander, MD, University of Aarhus:
Magnetic resonance imaging
Brain
Neuropsychology
Heart Defects, Congenital
Follow-Up Studies
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Diseases
Cardiovascular Abnormalities