Congenital Heart DiseaseNCT04041557
Executive Functions in Adults With Congenital Heart Disease
An observational study of Congenital Heart Disease, run by University Children's Hospital, Zurich.
Trial summary
Research in children with congenital heart disease (CHD) requiring cardiopulmonary bypass surgery in the neonatal period or during early childhood has shown that the survival rate for this population has dramatically increased, also for those with the most severe forms of CHD. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 20 Sep 2018
- 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 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: adults with congenital heart disease followed at the University Hospital Zürich
Who may be able to join
- •Congenital heart disease
Who cannot join
- •Genetic condition
About this study
Official title: Intellectual and Executive Functions in Relation to Cerebral MRI in Young Adults With Congenital Heart Disease
Research in children with congenital heart disease (CHD) requiring cardiopulmonary bypass surgery in the neonatal period or during early childhood has shown that the survival rate for this population has dramatically increased, also for those with the most severe forms of CHD. However, they are at significant risk for neurodevelopmental impairments, persisting into adolescence. Our research group showed that adolescents with CHD have smaller brain volumes than controls and that volume reduction correlates with poorer neurocognitive functioning. It is not known whether similar changes can also be found in adults with CHD (ACHD).
Aims:
Read more
- To determine intellectual and executive functions in young adults with congenital heart disease after childhood cardiopulmonary bypass surgery and to relate these findings to results on cerebral magnetic resonance imaging (MRI).
- To evaluate risk factors for adverse outcome and alteration on cerebral MRI.
- To examine the effect of poorer intellectual and executive functioning on academic achievement, quality of life, and psychosocial functioning.
Methodology:
Outcome variables: Intellectual and executive functioning as well as cerebral MRI.
Participants: Study subjects will be recruited from a large cohort that has been enrolled in a study on quality of life in ACHD. The investigators aim to include a maximum of 60 subjects per group (ACHD, controls). Variables and risk factors influencing outcome have already been assessed through that study. Cerebral MRI will be analysed for structural abnormalities, and volumetric, morphometric as well as connectivity analyses will be performed to comprehensively characterize cerebral architecture in ACHD and to compare it with that of healthy controls.
Inclusion criteria: Patients with congenital heart disease, cardiopulmonary bypass surgery during childhood, age 18 to 30 years Exclusion criteria: Known genetic syndromes or chromosomal abnormalities as well as other congenital or acquired diseases leading to mental disabilities, exclusion criteria for cerebral MRI.
Read the detailed description
The overall aim of our project is to study intellectual and executive functions in relation to cerebral magnetic resonance imaging (MRI) in young adults with severe congenital heart disease (CHD). Risk factors for poorer function and altered brain structure will be examined. This will extend the knowledge on the spectrum of potential long-term impairments, risk factors and the effect on the patient's quality of life. Only a better understanding of the spectrum and contributing factors of neurocognitive impairments in adults will allow for an early therapy in childhood and will prevent or ameliorate long-term sequelae for patients with CHD.
Specific aims:
- To determine the intellectual and executive function of young adults with congenital heart disease after cardiopulmonary bypass surgery during infancy or childhood Hypothesis: Intellectual outcome is within the normal range but below that of controls and assume to find specific difficulties in certain areas of executive functions.
- To perform cerebral MRI and perform morphometric analyses Hypothesis: Cerebral volumes will be smaller and regional white matter microstructure will be altered, which correlate with intellectual and executive function
- To determine patient and medical risk factors associated with adverse outcome Hypothesis: Disease severity correlates with intellectual outcome.
- To determine the associations between intellectual and executive function and quality of life Hypothesis: Functional outcome correlates with quality of life.
Subjects:
The patients and controls have participated in a study on quality of life in adults with CHD and will be asked to return for this part of the study. So far, 180 patients and 145 controls have been enrolled.
Inclusion Criteria:
- Patients with congenital heart disease
- Bypass surgery for congenital heart disease
- Male and female subject 18 to 30 years of age
- Written informed consent by the participant after information about the project
- In command of the German language
- No exclusion criteria for cerebral MRI
Exclusion Criteria:
- Known genetic syndromes or chromosomal abnormalities as well as other congenital or acquired diseases leading to mental disabilities
- Exclusion criteria for cerebral MRI
Outcome measures:
Intelligence will be assessed with the Wechsler Adult Intelligence Scale IV edition.
A large battery using standardized tests will be administered for the executive function assessment. This includes the following domains: Working and visual memory, inhibition, flexibility, planning, fluency, attention and questionnaires will assess the everyday functioning regarding executive functions (behavior rating inventory of executive functions-BRIEF).
Medical and sociodemographic data These data have already been obtained by the ongoing study.
Cerebral MRI MRI will be performed with a 3.0-T whole-body system (Signa Twinspeed Excite; GE Healthcare, Milwaukee, Wisconsin). Three-dimensional anatomic images of the entire brain will be obtained using a T1-weighted gradient echo pulse sequence (repetition time, 25 msec; echo time, 5 msec) and a T2-weighted spin echo pulse sequence (repetition time,6660 msec; echo time, 97.6 msec).
Time schedule Recruitment and testing phase 6-9 months, data entry, data control and preliminary data analysis 3 months.
Start of the project: January 1st, 2017, duration: 1 year.
Statistical Plan The sample size estimated is 51 participants per group given a two-sided alpha of 0.05 and a power of 90% resulting in a total of 102 participants for the study. In order to control for drop-outs, each group will comprise 60 subjects. Data will be analyzed using SPSS statistic software version 23 (SPSS inc., Chicago). Parametric or non-parametric procedures will be used to compare patients and controls with regard to outcome variables. To examine the role of predictors for the outcomes multivariate regression analyses will be performed.
Ethics Ethical approval is available for the assessment of neurocognitive and executive functions. An amendment is currently being submitted for the cerebral MRI part.
- Conditions
- Congenital Heart Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| adults with CHD | Adults with congenital heart disease 18-32 years of age | |
| controls | healthy peers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intellectual performance
short version of the adult WISC form
Measured: 1.1.17-30.9.18
Executive function global score
A score that is derived from averaging the T-values of the following executive function tests: color-word-interference test of the Delis-Kaplan-Executive Function System (D-KEFS) and the stop-signal task of the STOP-IT-both measuring inhibition, the S word of the Regensburger Wortflüssigkeitstest-measuring fluency, the Standardized Links' Probe-measuring planning, and the Trail Making Test -measuring cognitive flexibility.
Value: Mean 50 (+/-10), higher value better performance
Measured: 1.1.17-30.9.18
Secondary outcomes (1)
total brain volume on cerebral MRI
the total brain volume will be measured with a standardized protocol (free surfer) and expressed as mm3 (larger number equals larger brain)
Measured: 1.1.17-30.9.18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Jan 2017
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bea Latal, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041557
- Sponsor's protocol ID
- GUCHZurich
- Status last verified
- Aug 2019
- First submitted
- 4 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kessler N, Feldmann M, Schlosser L, Rometsch S, Brugger P, Kottke R, Knirsch W, Oxenius A, Greutmann M, Latal B. Structural brain abnormalities in adults with congenital heart disease: Prevalence and association with estimated intelligence quotient. Int J Cardiol. 2020 May 1;306:61-66. doi: 10.1016/j.ijcard.2020.02.061. Epub 2020 Feb 24.
PubMed 32143921
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intellectual and Executive Functions in Relation to Cerebral MRI in Young Adults With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT04041557
- Acronym / sponsor ID
- GUCHZurich
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 1 Aug 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.
Research in children with congenital heart disease (CHD) requiring cardiopulmonary bypass surgery in the neonatal period or during early childhood has shown that the survival rate for this population has dramatically increased, also for those with the most severe forms of CHD. However, they are at significant risk for neurodevelopmental impairments, persisting into adolescence. Our research group showed that adolescents with CHD have smaller brain volumes than controls and that volume reduction correlates with poorer neurocognitive functioning. It is not known whether similar changes can also be found in adults with CHD (ACHD).
Aims:
- To determine intellectual and executive functions in young adults with congenital heart disease after childhood cardiopulmonary bypass surgery and to relate these findings to results on cerebral magnetic resonance imaging (MRI).
- To evaluate risk factors for adverse outcome and alteration on cerebral MRI.
- To examine the effect of poorer intellectual and executive functioning on academic achievement, quality of life, and psychosocial functioning.
Methodology:
Outcome variables: Intellectual and executive functioning as well as cerebral MRI.
Participants: Study subjects will be recruited from a large cohort that has been enrolled in a study on quality of life in ACHD. The investigators aim to include a maximum of 60 subjects per group (ACHD, controls). Variables and risk factors influencing outcome have already been assessed through that study. Cerebral MRI will be analysed for structural abnormalities, and volumetric, morphometric as well as connectivity analyses will be performed to comprehensively characterize cerebral architecture in ACHD and to compare it with that of healthy controls.
Inclusion criteria: Patients with congenital heart disease, cardiopulmonary bypass surgery during childhood, age 18 to 30 years Exclusion criteria: Known genetic syndromes or chromosomal abnormalities as well as other congenital or acquired diseases leading to mental disabilities, exclusion criteria for cerebral MRI.
Detailed description
The overall aim of our project is to study intellectual and executive functions in relation to cerebral magnetic resonance imaging (MRI) in young adults with severe congenital heart disease (CHD). Risk factors for poorer function and altered brain structure will be examined. This will extend the knowledge on the spectrum of potential long-term impairments, risk factors and the effect on the patient's quality of life. Only a better understanding of the spectrum and contributing factors of neurocognitive impairments in adults will allow for an early therapy in childhood and will prevent or ameliorate long-term sequelae for patients with CHD.
Specific aims:
- To determine the intellectual and executive function of young adults with congenital heart disease after cardiopulmonary bypass surgery during infancy or childhood Hypothesis: Intellectual outcome is within the normal range but below that of controls and assume to find specific difficulties in certain areas of executive functions.
- To perform cerebral MRI and perform morphometric analyses Hypothesis: Cerebral volumes will be smaller and regional white matter microstructure will be altered, which correlate with intellectual and executive function
- To determine patient and medical risk factors associated with adverse outcome Hypothesis: Disease severity correlates with intellectual outcome.
- To determine the associations between intellectual and executive function and quality of life Hypothesis: Functional outcome correlates with quality of life.
Subjects:
The patients and controls have participated in a study on quality of life in adults with CHD and will be asked to return for this part of the study. So far, 180 patients and 145 controls have been enrolled.
Inclusion Criteria:
- Patients with congenital heart disease
- Bypass surgery for congenital heart disease
- Male and female subject 18 to 30 years of age
- Written informed consent by the participant after information about the project
- In command of the German language
- No exclusion criteria for cerebral MRI
Exclusion Criteria:
- Known genetic syndromes or chromosomal abnormalities as well as other congenital or acquired diseases leading to mental disabilities
- Exclusion criteria for cerebral MRI
Outcome measures:
Intelligence will be assessed with the Wechsler Adult Intelligence Scale IV edition.
A large battery using standardized tests will be administered for the executive function assessment. This includes the following domains: Working and visual memory, inhibition, flexibility, planning, fluency, attention and questionnaires will assess the everyday functioning regarding executive functions (behavior rating inventory of executive functions-BRIEF).
Medical and sociodemographic data These data have already been obtained by the ongoing study.
Cerebral MRI MRI will be performed with a 3.0-T whole-body system (Signa Twinspeed Excite; GE Healthcare, Milwaukee, Wisconsin). Three-dimensional anatomic images of the entire brain will be obtained using a T1-weighted gradient echo pulse sequence (repetition time, 25 msec; echo time, 5 msec) and a T2-weighted spin echo pulse sequence (repetition time,6660 msec; echo time, 97.6 msec).
Time schedule Recruitment and testing phase 6-9 months, data entry, data control and preliminary data analysis 3 months.
Start of the project: January 1st, 2017, duration: 1 year.
Statistical Plan The sample size estimated is 51 participants per group given a two-sided alpha of 0.05 and a power of 90% resulting in a total of 102 participants for the study. In order to control for drop-outs, each group will comprise 60 subjects. Data will be analyzed using SPSS statistic software version 23 (SPSS inc., Chicago). Parametric or non-parametric procedures will be used to compare patients and controls with regard to outcome variables. To examine the role of predictors for the outcomes multivariate regression analyses will be performed.
Ethics Ethical approval is available for the assessment of neurocognitive and executive functions. An amendment is currently being submitted for the cerebral MRI part.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adults with CHD | – | –Adults with congenital heart disease 18-32 years of age |
| controls | – | –healthy peers |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adults with congenital heart disease followed at the University Hospital Zürich
Key inclusion criteria (1 listed)
- •Congenital heart disease
Key exclusion criteria (1 listed)
- •Genetic condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intellectual performance
Time frame: 1.1.17-30.9.18
short version of the adult WISC form
Executive function global score
Time frame: 1.1.17-30.9.18
A score that is derived from averaging the T-values of the following executive function tests: color-word-interference test of the Delis-Kaplan-Executive Function System (D-KEFS) and the stop-signal task of the STOP-IT-both measuring inhibition, the S word of the Regensburger Wortflüssigkeitstest-measuring fluency, the Standardized Links' Probe-measuring planning, and the Trail Making Test -measuring cognitive flexibility. Value: Mean 50 (+/-10), higher value better performance
1 secondary outcome
total brain volume on cerebral MRI
Time frame: 1.1.17-30.9.18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Derived from this study: PubMed 32143921Kessler N, Feldmann M, Schlosser L, Rometsch S, Brugger P, Kottke R, Knirsch W, Oxenius A, Greutmann M, Latal B. Structural brain abnormalities in adults with congenital heart disease: Prevalence and association with estimated intelligence quotient. Int J Cardiol. 2020 May 1;306:61-66. doi: 10.1016/j.ijcard.2020.02.061. Epub 2020 Feb 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by University Children's Hospital, Zurich.
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: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intellectual performance (time frame: 1.1.17-30.9.18). The study lists 2 primary outcomes in all. 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 NCT04041557, which also lists 1 linked publication.
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 5 Aug 2019.