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

Not Applicable

Completed

• Conditions: Long QT Syndrome; Catecholaminergic Polymorphic Ventricular Tachycardia; Arrhythmogenic Right Ventricular Dysplasia; Hypertrophic Cardiomyopathy; Restrictive Cardiomyopathy; Dilated Cardiomyopathy; Brugada Syndrome
• Interventions: Other: MRI

• Registration Number: NCT04712136
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-15
• Study Start: 2021-02-01
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Male or female aged 6 to 18 years old.
• Group 1: Patients with an inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or those with an inherited cardiomyopathy (hypertrophic, dilated, or restrictive cardiomyopathy).
• Group 2: Children with a completely normal check-up, referred to the paediatric cardiology consultation for a non-severe functional symptom linked to exercise (murmur, palpitation, or dyspnoea) or for a medical sports certificate.
• Informed consent of parents or legal guardians, and oral assent of children

Exclusion Criteria

• Patients who are not able to understand or fill out the questionnaires (QoL, physical activity and motivation questionnaires).
• Absolute contraindications for CPET: fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or haemodynamic compromise, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction, and children with mental impairment leading to inability to cooperate.
• Group 2: Children with any chronic disease, medical condition (cardiac, neurologic, respiratory, muscular, or renal), or medical treatment and those requiring any further specialized medical consultation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	MRI	Children aged 6 to 18 years old referred to the paediatric cardiology consultation who were classified in the control group after a completely normal check-up, including physical examination, electrocardiogram, and echocardiography.
Cardiac disease	MRI	Children aged of 6 to 18 years old with an inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or those with an inherited cardiomyopathy (hypertrophic, dilated, or restrictive cardiomyopathy).

Primary Outcome Measures

Name	Time	Method
Total score of health-reported quality of life self questionnaire	baseline (1 day)	PedsQL questionnaire

Secondary Outcome Measures

Name	Time	Method
Exercise capacity	baseline (1 day)	Cardiopulmonary exercise test with VO2max assessment
Myocardial morphologic assessment	baseline (1 day)	cardiac MRI
The metabolic equivalent of task	during 14 days after inclusion	measured by the wearable actimeter device.
physical activity level	baseline (1 day)	Ricci and Gagnon questionnaire
Motivation towards health-oriented physical activity	baseline (1 day)	EMAPS motivation scale

Trial Locations

Locations (1)

CHU Arnaud de Villeneuve; 🇫🇷 Montpellier, Occitanie, France