Abstract

Background

Advances in paediatric cardiology have improved the prognosis of children with inherited cardiac disorders. However, health-related quality of life (QoL) and physical activity have been scarcely analysed in children with inherited cardiac arrhythmia or inherited cardiomyopathy. Moreover, current guidelines on the eligibility of young athletes with inherited cardiac disorders for sports participation mainly rely on expert opinions and remain controversial.

Methods

The QUALIMYORYTHM trial is a multicentre observational controlled study. The main objective is to compare the QoL of children aged 6 to 17 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or inherited cardiomyopathy (hypertrophic, dilated, or restrictive cardiomyopathy), to that of age and gender-matched healthy subjects. The secondary objective is to assess their QoL according to the disease’s clinical and genetic characteristics, the level of physical activity and motivation for sports, the exercise capacity, and the socio-demographic data. Participants will wear a fitness tracker (ActiGraph GT3X accelerometer) for 2 weeks. A total of 214 children are required to observe a significant difference of 7 ± 15 points in the PedsQL, with a power of 90% and an alpha risk of 5%.

Discussion

After focusing on the survival in children with inherited cardiac disorders, current research is expanding to patient-reported outcomes and secondary prevention. The QUALIMYORYTHM trial intends to improve the level of evidence for future guidelines on sports eligibility in this population.

Trial registration ClinicalTrials.gov Identifier: NCT04712136, registered on January 15th, 2021 (https://clinicaltrials.gov/ct2/show/NCT04712136).

Details

Title
Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods
Author
Amedro, Pascal  VIAFID ORCID Logo  ; Werner, Oscar; Hamouda Abassi; Boisson, Aymeric; Souilla, Luc; Guillaumont, Sophie; Calderon, Johanna; Requirand, Anne; Vincenti, Marie; Pommier, Victor; Matecki, Stefan; Gregoire De La Villeon; Lavastre, Kathleen; Lacampagne, Alain; Picot, Marie-Christine; Beyler, Constance; Delclaux, Christophe; Dulac, Yves; Guitarte, Aitor; Charron, Philippe; Denjoy-Urbain, Isabelle; Probst, Vincent; Alban-Elouen Baruteau; Chevalier, Philippe; Sylvie Di Filippo; Jean-Benoit Thambo; Bonnet, Damien; Pasquie, Jean-Luc
Pages
1-9
Section
Study protocol
Publication year
2021
Publication date
2021
Publisher
BioMed Central
e-ISSN
14777525
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s12955-021-01825-6
ProQuest document ID
2562642171
Copyright
© 2021. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.