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

Hypertrophic Cardiomyopathy Clinical Trial

— QUALIMYORYTHM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04712136
• Other study ID #: RECHMPL19-0554
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2023
• Source: University Hospital, Montpellier
• Contact: Pascal AMEDRO, MD
• Phone: 0467336632
• Email: p-amedro[@]chu-montpellier.fr
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 214
• Est. completion date: February 1, 2024
• Est. primary completion date: December 1, 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.

Related Conditions & MeSH terms

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

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

Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study Front. Cardiovasc. Med., 11 January 2023 Sec. Pediatric Cardiology Volume 9 - 2022 | https://doi.org/10.3389/fcvm.2022.1081106

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)