Heart Defects, CongenitalNCT03871881
Impact of Congenital Heart Disease on Neurodevelopmental Outcome
An observational study of Heart Defects, Congenital, run by University of Aarhus at 1 site in Denmark.
Trial summary
The project aims toward clarifying the underlying mechanism and the long-term impact of congenital heart disease on neurodevelopment. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Magnetic Resonance Imaging and Neuropsychological assessment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2017to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants are either adults who in childhood were diagnosed with an ASD or VSD, or healthy matched controls.
Who may be able to join
- ICD codes DX Q21.0 (VSD) or DX Q21.1 (ASD), surgically repaired VSD or open ASD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Magnetic Resonance Imaging, Neuropsychological assessment
- Keywords
- Magnetic resonance imaging, Brain, Neuropsychology, Heart Defects, Congenital, Follow-Up Studies
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)
Neuropsychological assessmentOther
A special designed neuropsychological test battery of validated tests to assess function of cognitive domains
| Study group | Role | What they receive |
|---|---|---|
| Atrial septal defect | Patients with an open atrial septal defect, diagnosed in childhood Receives: Other: Magnetic Resonance Imaging; Other: Neuropsychological assessment | |
| Ventricular septal defect | Patients who had surgical closure of a ventricular septal defect in childhood Receives: Other: Magnetic Resonance Imaging; Other: Neuropsychological assessment | |
| Healthy control | Healthy, young adults matched on age, gender and education Receives: Other: Magnetic Resonance Imaging; Other: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term impact of congenital heart disease on brain development
MRI analysis
Measured: 12 months
Secondary outcomes (1)
Long-term impact of congenital heart disease on neurocognitive outcome
Neuropsychological assessment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Jul 2017
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Benjamin Asschenfeldt Arlander, MD, University of Aarhus
- Investigators
- Vibeke Hjortdal, MD, PhD, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871881
- Sponsor's protocol ID
- Brain&CHD
- Status last verified
- Aug 2020
- First submitted
- 22 Nov 2017
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35699183Lau-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.
PubMed 34938699Asschenfeldt 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.
PubMed 33745293Asschenfeldt 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.
PubMed 32427039
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Congenital Heart Disease on Neurodevelopmental Outcome and Comorbidity in Adulthood
- ClinicalTrials.gov ID
- NCT03871881
- Acronym / sponsor ID
- Brain&CHD
- Conditions
- Heart Defects, Congenital
- Keywords
- Magnetic resonance imaging, Brain, Neuropsychology, Heart Defects, Congenital, Follow-Up Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atrial septal defect | – | Other: Magnetic Resonance Imaging, Other: Neuropsychological assessmentPatients with an open atrial septal defect, diagnosed in childhood |
| Ventricular septal defect | – | Other: Magnetic Resonance Imaging, Other: Neuropsychological assessmentPatients who had surgical closure of a ventricular septal defect in childhood |
| Healthy control | – | Other: Magnetic Resonance Imaging, Other: Neuropsychological assessmentHealthy, young adults matched on age, gender and education |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants are either adults who in childhood were diagnosed with an ASD or VSD, or healthy matched controls.
Key inclusion criteria (1 listed)
- ICD codes DX Q21.0 (VSD) or DX Q21.1 (ASD), surgically repaired VSD or open ASD
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingMagnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI) | Other | Atrial septal defect, Healthy control, Ventricular septal defect |
| Neuropsychological assessmentA special designed neuropsychological test battery of validated tests to assess function of cognitive domains | Other | Atrial septal defect, Healthy control, Ventricular septal defect |
Primary outcome
Long-term impact of congenital heart disease on brain development
Time frame: 12 months
MRI analysis
1 secondary outcome
Long-term impact of congenital heart disease on neurocognitive outcome
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Derived from this study: PubMed 35699183Asschenfeldt 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.
- Derived from this study: PubMed 34938699Lau-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.
- Derived from this study: PubMed 33745293Asschenfeldt 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.
- Derived from this study: PubMed 32427039Asschenfeldt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke Hjortdal, MD, PhD study chair
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term impact of congenital heart disease on brain development (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03871881, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.