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

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: t
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• 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

Locations
Other Locations
France
CHU Arnaud de Villeneuve
Montpellier
Time Frame
Start Date: 2021-02-01
Completion Date: 2023-06-20
Participants
Target number of participants: 214
Treatments
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).
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.
Sponsors
Collaborators: Hôpital Necker-Enfants Malades, Hospices Civils de Lyon, University Hospital, Toulouse, Nantes University Hospital, University Hospital, Bordeaux, Hopital Lariboisière, Saint Pierre Institute - Palavas les Flots
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov