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NCT04812210: QoLCHD

Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years

Completed Last updated 12 April 2022
What this trial tests

trial in Congenital Heart Disease in 248 participants. Completed in 30 December 2021.

Timeline
1 April 2021
Primary endpoint
1 December 2021
30 December 2021

Quick facts

Lead sponsorUniversity Hospital, Montpellier
StatusCompleted
Study typeOBSERVATIONAL
Enrollment248
Start date1 April 2021
Primary completion1 December 2021
Estimated completion30 December 2021
Sites1 location across France

Conditions studied

Sponsor

University Hospital, Montpellier

Who can join

Adults 2 to 4, any sex, with Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Nowadays, health-related quality of life (HRQoL) assessment of this population is in the foreground. Our team is a tertiary care center for management of patients with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on HRQoL in pediatric and CHD. The investigators thus demonstrated the link between cardiopulmonary fitness and HRQoL in children with CHD aged 8 to 18 years, the correlation between functional class and HRQoL in adults with CHD, the impact of therapeutic education on HRQoL in children under anticoagulants and the lack of difference between the HRQoL of children CHD aged 5 to 7 years old and that of control children. Currently, no controlled cross-sectional quality of life study assessment has been leded in the youngest children with CHD. This present study therefore extends our work in younger children aged 2 to 4 years.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Congenital Heart Disease

Currently open trials in the same condition.

Other University Hospital, Montpellier trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04812210.

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