Status:
COMPLETED
Healthy-related Quality of Life and Physical Activity of Children With Cardiac Malformations
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Saint Pierre Institute - Palavas les Flots
University Hospital, Toulouse
Conditions:
Long QT Syndrome
Brugada Syndrome
Eligibility:
All Genders
6-18 years
Phase:
NA
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 syn...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04712136
Start Date
February 1 2021
End Date
June 20 2023
Last Update
April 2 2025
Active Locations (1)
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1
CHU Arnaud de Villeneuve
Montpellier, Occitanie, France, 34090