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

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

Interventions

OTHER

MRI

MRI cardiac

Sponsors & Collaborators

• Saint Pierre Institute - Palavas les Flots

  collaborator UNKNOWN

• University Hospital, Toulouse

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• Hopital Lariboisière

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• University Hospital, Montpellier

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-01

Primary Completion

2023-06-20

Completion

2023-06-20

Countries

• France

Study Locations