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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dilated Cardiomyopathy; Hypertrophic Cardiomyopathy; Brugada Syndrome; Long QT Syndrome; Arrhythmogenic Right Ventricular Dysplasia; Catecholaminergic Polymorphic Ventricular Tachycardia; Restrictive Cardiomyopathy
• Intervention / Treatment: Other: MRI

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 Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Montpellier, Occitanie, France, 34090
      • Recruiting
      • CHU Arnaud de Villeneuve
      • Contact: Pascal AMEDRO, PhD; Phone Number: +33 (0) 4 67 33 66 39; Email: p-amedro@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score of health-reported quality of life self questionnaire	PedsQL questionnaire	baseline (1 day)

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): February 1, 2024

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (ACTUAL): January 15, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; Life quality; Paediatric cardiology; Inherited cardiac arrhythmia; Genetic cardiomyopathies
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiomegaly; Laminopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Syndrome; Tachycardia; Tachycardia, Ventricular; Cardiomyopathies; Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic; Brugada Syndrome; Long QT Syndrome; Arrhythmogenic Right Ventricular Dysplasia; Cardiomyopathy, Restrictive
• Other Study ID Numbers: RECHMPL19-0554

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No