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

Health and Quality of Life Outcomes

Jean-Luc Pasquie¹  Vincent Probst²  Philippe Charron³  Isabelle Denjoy-Urbain³  Philippe Chevalier⁴  Sylvie Di Filippo⁴  Pascal Amedro⁵  Jean-Benoit Thambo⁵  Alban-Elouen Baruteau⁶  Marie-Christine Picot⁷  Yves Dulac⁸  Aitor Guitarte⁸  Damien Bonnet⁹  Constance Beyler^1,10  Christophe Delclaux^1,10  Anne Requirand^1,11  Oscar Werner^1,11  Aymeric Boisson^1,11  Kathleen Lavastre^1,11  Luc Souilla^1,11  Victor Pommier^1,12  Sophie Guillaumont^1,12  Gregoire De La Villeon^1,12  Marie Vincenti^1,13  Hamouda Abassi^1,13  Johanna Calderon^1,13  Stefan Matecki^1,13  Alain Lacampagne^1,14 

[1] Cardiology Department of Cardiology, Regional Reference Centre for Inherited Cardiac Arrhythmia, Montpellier University Hospital, Montpellier, France;PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier, France;Department of Cardiology, National Reference Centre for Inherited Cardiac Arrhythmia, L’institut du thorax, INSERM, CNRS, University of Nantes, Nantes University Hospital, Nantes, France;Department of Cardiology, National Reference Centre for Inherited Cardiomyopathy, University of Paris, AP-HP, Paris, France;Department of Congenital Cardiology, National Reference Centre for Inherited Cardiac Arrhythmia, University of Lyon, Lyon University Hospital, Lyon, France;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;INSERM, Bordeaux Cardio-Thoracic Research Centre, U1045, University of Bordeaux, Pessac, France;IHU Liryc, Electrophysiology and Heart Modelling Institute, Fondation Bordeaux Université, Pessac, France;Department of Pediatric Cardiology and Pediatric Cardiac Surgery, L’Institut du Thorax, INSERM, CNRS, University of Nantes, Nantes University Hospital, Nantes, France;Epidemiology and Clinical Research Department, Montpellier University Hospital, Montpellier, France;Paediatric Cardiology Department, M3C Regional Reference Centre, Toulouse University Hospital, Toulouse, France;Paediatric Cardiology Department, Necker-Enfants malades, M3C National Reference Centre, University of Paris, AP-HP, Paris, France;Paediatric Cardiology and Physiology Department, Robert Debré University Hospital, University of Paris, AP-HP, Paris, France;Paediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University Hospital, Montpellier, France;Paediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University Hospital, Montpellier, France;Paediatric Cardiology and Rehabilitation Unit, Institut-Saint-Pierre, Palavas-Les-Flots, France;Paediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University Hospital, Montpellier, France;PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier, France;PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier, France;

关键词: Quality of life;    Physical activity;    Paediatrics;    Inherited cardiac arrhythmia;    Genetic cardiomyopathy;   

DOI  :  10.1186/s12955-021-01825-6

来源: Springer

【 摘 要 】

BackgroundAdvances 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.MethodsThe 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%.DiscussionAfter 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).

【 授权许可】

CC BY