Impact of Congenital Heart Disease on Neurodevelopmental Outcome

May 7, 2021 updated by: Benjamin Asschenfeldt Arlander, MD, University of Aarhus

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term impact of congenital heart disease on brain development
Time Frame: 12 months
MRI analysis
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term impact of congenital heart disease on neurocognitive outcome
Time Frame: 12 months
Neuropsychological assessment
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Study Chair: Vibeke Hjortdal, MD, PhD, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

March 11, 2019

First Posted (ACTUAL)

March 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brain&CHD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Defects, Congenital

Clinical Trials on Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe