CompletedNot Applicable

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

France214 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study is completed, has the data been published yet, and could you walk me through what the findings showed about quality of life in children with conditions like ours?
2This trial looked at health-related quality of life in children with serious heart rhythm and cardiomyopathy conditions — based on what it found, are there any specific lifestyle or activity recommendations you'd make for my child's particular diagnosis?
3The study measured physical activity alongside quality of life — do the results suggest that children with conditions like Long QT Syndrome or hypertrophic cardiomyopathy can safely participate in regular physical activity, and how does that apply to my child?
4Since this was an observational study using questionnaires rather than testing a treatment, does the data from this research change how you think about monitoring or supporting my child's emotional and physical wellbeing alongside their medical care?
5Given that the study included several different heart conditions, how closely do the findings apply to my child's specific diagnosis, and are there other studies you'd recommend we look at together?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total score of health-reported quality of life self questionnaire

Timeframe: baseline (1 day)

Trial details

NCT IDNCT04712136

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-20

View on ClinicalTrials.gov More Long QT Syndrome trials