NCT04712136: QUALIMYORYTHM

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

Completed NA Last updated 2 April 2025

What this trial tests

NA trial testing MRI in Long QT Syndrome in 214 participants. Completed in 20 June 2023.

Timeline

1 February 2021

Primary endpoint
20 June 2023

20 June 2023

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	214
Start date	1 February 2021
Primary completion	20 June 2023
Estimated completion	20 June 2023
Sites	1 location across France

Drugs / interventions tested

• MRI — full drug profile →

Conditions studied

• Long QT Syndrome — all drugs for Long QT Syndrome →
• Brugada Syndrome — all drugs for Brugada Syndrome →
• Catecholaminergic Polymorphic Ventricular Tachycardia — all drugs for Catecholaminergic Polymorphic Ventricular Tachycardia →
• Arrhythmogenic Right Ventricular Dysplasia — all drugs for Arrhythmogenic Right Ventricular Dysplasia →

Sponsor

University Hospital, Montpellier

Who can join

Adults 6 to 18, any sex, with Long QT Syndrome or Brugada Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Amedro P, Werner O, Abassi H, Boisson A, et al · · 2021 · cited 12× · PMID 34321045 · DOI 10.1186/s12955-021-01825-6
2. Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study.
   Souilla L, Avesani M, Boisson A, Requirand A, et al · · 2022 · cited 8× · PMID 36712265 · DOI 10.3389/fcvm.2022.1081106
3. Cardiopulmonary Fitness and Physical Activity Among Children and Adolescents With Inherited Cardiac Disease.
   Souilla L, Werner O, Huguet H, Gavotto A, et al · · 2025 · cited 5× · PMID 39998828 · DOI 10.1001/jamanetworkopen.2024.61795
4. Brugada Syndrome and Exercise: Is It Time for a Paradigm Change?
   Gonçalves CM, Vazão A, Carvalho M, Cabral M, et al · · 2025 · cited 2× · PMID 40137092 · DOI 10.3390/jcdd12030094
5. Use of T1 mapping in cardiac MRI for the follow-up of Fabry disease in a pediatric population.
   Werner O, Ichay L, Djouadi N, Vetromile F, et al · · 2024 · PMID 38234860 · DOI 10.1016/j.ymgmr.2023.101044
6. Health-Related Quality of Life and Physical Activity in Children with Inherited Cardiac Arrhythmia or Inherited Cardiomyopathies: The Prospective Multicentre Controlled QUALIMYORYTHM Study Rationale, Design and Methods.
   Amedro P, Werner O, Abassi H, Boisson A, et al · · 2021 · DOI 10.21203/rs.3.rs-410935/v1