NCT04712136

Healthy-related Quality of Life and Physical Activity of Children With Cardiac Malformations

Healthy-related Quality of Life and Physical Activity of Children With Inherited Cardiac Arrhythmia or Inherited Cardiomyopathies: the Prospective Multicentre Controlled QUALIMYORYTHM Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The QUALIMYORYTHM trial is a multicentre controlled study, aiming to assess health-related quality of life (HRQoL) of 107 children aged 6 to 18 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or inherited cardiomyopathies (hypertrophic, dilated, or restrictive cardiomyopathy), and to compare the results to those of 107 age and gender-matched healthy subjects. The secondary objective is to assess, in this population, the HRQoL according to disease characteristics, level of physical activity, exercise capacity, and socio-demographic data. Participants will wear a fitness tracker for 2 weeks.

Detailed description

Advances in paediatric cardiology has improved the prognosis of children with inherited cardiac disorders. However, quality of life and physical activity have been scarcely analysed in children with inherited cardiac arrhythmia or inherited cardiomyopathies. Moreover, current guidelines on the eligibility of young athletes with inherited cardiac disorders for sports participation mainly rely on expert opinions and remain controversial. The QUALIMYORYTHM trial is a multicentre controlled study. The main objective is to compare health-related quality of life (HRQoL) of children aged 6 to 18 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or inherited cardiomyopathies (hypertrophic, dilated, or restrictive cardiomyopathy), to that of age and gender-matched healthy subjects. The secondary objective is to assess, in this population, HRQoL according to the disease clinical and genetic characteristics, the level of physical activity and motivation for sports, the exercise capacity (VO2max), and the socio-demographic data. Participants will wear a fitness tracker (actimeter watch) 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%. The QUALIMYORYTHM trial intends to improve the level of evidence for future guidelines on sports eligibility in this population.

Conditions

• Long QT Syndrome
• Brugada Syndrome
• Catecholaminergic Polymorphic Ventricular Tachycardia
• Arrhythmogenic Right Ventricular Dysplasia
• Hypertrophic Cardiomyopathy
• Dilated Cardiomyopathy
• Restrictive Cardiomyopathy

Interventions

Type	Name	Description
OTHER	MRI	MRI cardiac

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-06-20
• Completion: 2023-06-20
• First posted: 2021-01-15
• Last updated: 2025-04-02

Locations

1 site across 1 country: France