Pascal Amedro1,2,3, Oscar Werner4, Hamouda Abassi4,5, Aymeric Boisson4, Luc Souilla4, Sophie Guillaumont4,6, Johanna Calderon4,5, Anne Requirand4, Marie Vincenti4,5, Victor Pommier4,6, Stefan Matecki4,5, Gregoire De La Villeon4,6, Kathleen Lavastre4, Alain Lacampagne5, Marie-Christine Picot7, Constance Beyler8, Christophe Delclaux8, Yves Dulac9, Aitor Guitarte9, Philippe Charron10, Isabelle Denjoy-Urbain10, Vincent Probst11, Alban-Elouen Baruteau12, Philippe Chevalier13, Sylvie Di Filippo13, Jean-Benoit Thambo14,15,16, Damien Bonnet17, Jean-Luc Pasquie18,5. 1. Department of Paediatric and Adult Congenital Cardiology, M3C National Reference Centre, Haut-Lévêque Cardiology Hospital, Bordeaux University Hospital, Avenue de Magellan, 33604, Pessac Cedex, France. pascal.amedro@gmail.com. 2. INSERM, Bordeaux Cardio-Thoracic Research Centre, U1045, University of Bordeaux, Pessac, France. pascal.amedro@gmail.com. 3. IHU Liryc, Electrophysiology and Heart Modelling Institute, Fondation Bordeaux Université, Pessac, France. pascal.amedro@gmail.com. 4. Paediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University Hospital, Montpellier, France. 5. PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier, France. 6. Paediatric Cardiology and Rehabilitation Unit, Institut-Saint-Pierre, Palavas-Les-Flots, France. 7. Epidemiology and Clinical Research Department, Montpellier University Hospital, Montpellier, France. 8. Paediatric Cardiology and Physiology Department, Robert Debré University Hospital, University of Paris, AP-HP, Paris, France. 9. Paediatric Cardiology Department, M3C Regional Reference Centre, Toulouse University Hospital, Toulouse, France. 10. Department of Cardiology, National Reference Centre for Inherited Cardiomyopathy, University of Paris, AP-HP, Paris, France. 11. Department of Cardiology, National Reference Centre for Inherited Cardiac Arrhythmia, L'institut du thorax, INSERM, CNRS, University of Nantes, Nantes University Hospital, Nantes, France. 12. Department of Pediatric Cardiology and Pediatric Cardiac Surgery, L'Institut du Thorax, INSERM, CNRS, University of Nantes, Nantes University Hospital, Nantes, France. 13. Department of Congenital Cardiology, National Reference Centre for Inherited Cardiac Arrhythmia, University of Lyon, Lyon University Hospital, Lyon, France. 14. Department of Paediatric and Adult Congenital Cardiology, M3C National Reference Centre, Haut-Lévêque Cardiology Hospital, Bordeaux University Hospital, Avenue de Magellan, 33604, Pessac Cedex, France. 15. INSERM, Bordeaux Cardio-Thoracic Research Centre, U1045, University of Bordeaux, Pessac, France. 16. IHU Liryc, Electrophysiology and Heart Modelling Institute, Fondation Bordeaux Université, Pessac, France. 17. Paediatric Cardiology Department, Necker-Enfants malades, M3C National Reference Centre, University of Paris, AP-HP, Paris, France. 18. Cardiology Department of Cardiology, Regional Reference Centre for Inherited Cardiac Arrhythmia, Montpellier University Hospital, Montpellier, France.
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 ).
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 ).
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