NCT04041557

Executive Functions in Adults With Congenital Heart Disease

Completed Last updated 5 August 2019

What this trial tests

trial in Congenital Heart Disease in 120 participants. Completed in 20 September 2018.

Timeline

1 January 2017

Primary endpoint
20 September 2018

20 September 2018

Quick facts

Lead sponsor	University Children's Hospital, Zurich
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	1 January 2017
Primary completion	20 September 2018
Estimated completion	20 September 2018

Conditions studied

• Congenital Heart Disease — all drugs for Congenital Heart Disease →

Sponsor

University Children's Hospital, Zurich

Who can join

Adults 18 to 32, any sex, with Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

1. 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).
2. To evaluate risk factors for adverse outcome and alteration on cerebral MRI.
3. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Structural brain abnormalities in adults with congenital heart disease: Prevalence and association with estimated intelligence quotient.
   Kessler N, Feldmann M, Schlosser L, Rometsch S, et al · · 2020 · cited 17× · PMID 32143921 · DOI 10.1016/j.ijcard.2020.02.061