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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04712136
Other study ID # RECHMPL19-0554
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date June 20, 2023

Study information

Verified date May 2024
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 214
Est. completion date June 20, 2023
Est. primary completion date June 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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


Intervention

Other:
MRI
MRI cardiac

Locations

Country Name City State
France CHU Arnaud de Villeneuve Montpellier Occitanie

Sponsors (8)

Lead Sponsor Collaborator
University Hospital, Montpellier Hopital Lariboisière, Hôpital Necker-Enfants Malades, Hospices Civils de Lyon, Nantes University Hospital, Saint Pierre Institute - Palavas les Flots, University Hospital, Bordeaux, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (2)

Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. 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 Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6. — View Citation

Souilla L, Avesani M, Boisson A, Requirand A, Matecki S, Vincenti M, Werner O, De La Villeon G, Pommier V, Pasquie JL, Guillaumont S, Amedro P. Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study. Front Cardiovasc Med. 2023 Jan 11;9:1081106. doi: 10.3389/fcvm.2022.1081106. eCollection 2022. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total score of health-reported quality of life self questionnaire PedsQL questionnaire baseline (1 day)
Secondary The metabolic equivalent of task measured by the wearable actimeter device. during 14 days after inclusion
Secondary physical activity level Ricci and Gagnon questionnaire baseline (1 day)
Secondary Motivation towards health-oriented physical activity EMAPS motivation scale baseline (1 day)
Secondary Exercise capacity Cardiopulmonary exercise test with VO2max assessment baseline (1 day)
Secondary Myocardial morphologic assessment cardiac MRI baseline (1 day)
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