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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT04712136

Collaborator

Saint Pierre Institute - Palavas les Flots (Other), University Hospital, Toulouse (Other), University Hospital, Bordeaux (Other), Hôpital Necker-Enfants Malades (Other), Hopital Lariboisière (Other), Nantes University Hospital (Other), Hospices Civils de Lyon (Other)

214

Enrollment

Location

Arms

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Long QT Syndrome Brugada Syndrome Catecholaminergic Polymorphic Ventricular Tachycardia Arrhythmogenic Right Ventricular Dysplasia Hypertrophic Cardiomyopathy Dilated Cardiomyopathy Restrictive Cardiomyopathy	Other: MRI	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

214 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiac disease 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).	Other: MRI MRI cardiac
Sham Comparator: Control group 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.	Other: MRI MRI cardiac

Arm

Intervention/Treatment

Experimental: Cardiac disease

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).

Other: MRI

MRI cardiac

Sham Comparator: Control group

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.

Other: MRI

MRI cardiac

Outcome Measures

Primary Outcome Measures

Total score of health-reported quality of life self questionnaire [baseline (1 day)]
PedsQL questionnaire

Secondary Outcome Measures

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
Exercise capacity [baseline (1 day)]
Cardiopulmonary exercise test with VO2max assessment
Myocardial morphologic assessment [baseline (1 day)]
cardiac MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.