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

NCT04712136 | Completed DMC

• 1 other identifier: RECHMPL19-0554
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Long QT Syndrome; Brugada Syndrome; Catecholaminergic Polymorphic Ventricular Tachycardia; Arrhythmogenic Right Ventricular Dysplasia; Hypertrophic Cardiomyopathy; Dilated Cardiomyopathy; Restrictive Cardiomyopathy

Keywords

Life quality; Physical activity; Paediatric cardiology; Inherited cardiac arrhythmia; Genetic cardiomyopathies

Outcome Measures

Primary Outcomes (1)

• Total score of health-reported quality of life self questionnaire

  PedsQL questionnaire

  baseline (1 day)

Secondary Outcomes (5)

• The metabolic equivalent of task

  during 14 days after inclusion

• physical activity level

  baseline (1 day)

• Motivation towards health-oriented physical activity

  baseline (1 day)

• Exercise capacity

  baseline (1 day)

• Myocardial morphologic assessment

  baseline (1 day)

Study Arms (2)

Cardiac disease

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

MRI OTHER

MRI cardiac

Cardiac disease; Control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

CHU Arnaud de Villeneuve

Montpellier, Occitanie, 34090, France

Location

Related Publications (4)

• 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.

  PMID: 34321045 BACKGROUND

• 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.

  PMID: 36712265 BACKGROUND

• Souilla L, Guillaumont S, Auer A, Metzler G, Requirand A, Vincenti M, De La Villeon G, Pasquie JL, Mottet D, Amedro P. Cardiac rehabilitation in children and adolescents with long QT syndrome: the RYTHMO'FIT pilot study. BMC Sports Sci Med Rehabil. 2024 Jul 12;16(1):152. doi: 10.1186/s13102-024-00941-2.

  PMID: 38997778 BACKGROUND

• Souilla L, Werner O, Huguet H, Gavotto A, Vincenti M, Pasquie JL, De La Villeon G, Guillaumont S, Pommier V, Matecki S, Baruteau AE, Beyler C, Delclaux C, Denjoy I, Charron P, Chevalier P, Deliniere A, Andrianoely M, Cornuault L, Besnard-Neyraud C, Sacher F, Reant P, Mottet D, Picot MC, Amedro P; Quality of Life in Children With Inherited Cardiomyopathy or Arrhythmia (QUALIMYORYTHM) Study Group. Cardiopulmonary Fitness and Physical Activity Among Children and Adolescents With Inherited Cardiac Disease. JAMA Netw Open. 2025 Feb 3;8(2):e2461795. doi: 10.1001/jamanetworkopen.2024.61795.

  PMID: 39998828 RESULT

MeSH Terms

Conditions

Long QT Syndrome; Brugada Syndrome; Polymorphic Catecholaminergic Ventricular Tachycardia; Arrhythmogenic Right Ventricular Dysplasia; Cardiomyopathy, Hypertrophic; Cardiomyopathy, Dilated; Cardiomyopathy, Restrictive; Motor Activity

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genetic Diseases, Inborn; Tachycardia, Ventricular; Tachycardia; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Cardiomegaly; Laminopathies; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 15, 2021
• Study Start: February 1, 2021
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

FR (1)