Hypertrophic Cardiomyopathy Clinical Trial
Official title:
Healthy-related Quality of Life and Physical Activity of Children With Inherited Cardiac Arrhythmia or Inherited Cardiomyopathies: the Prospective Multicentre Controlled QUALIMYORYTHM Study
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.
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 inherited cardiac arrhythmia or inherited cardiomyopathies. Moreover, current guidelines on the eligibility of young athletes with inherited cardiac disorders for sports participation mainly rely on expert opinions and remain controversial. The QUALIMYORYTHM trial is a multicentre controlled study. The main objective is to compare health-related quality of life (HRQoL) of 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), to that of age and gender-matched healthy subjects. The secondary objective is to assess, in this population, HRQoL according to the disease clinical and genetic characteristics, the level of physical activity and motivation for sports, the exercise capacity (VO2max), and the socio-demographic data. Participants will wear a fitness tracker (actimeter watch) for 2 weeks. A total of 214 children are required to observe a significant difference of 7 ± 15 points in the PedsQL, with a power of 90% and an alpha risk of 5%. The QUALIMYORYTHM trial intends to improve the level of evidence for future guidelines on sports eligibility in this population. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03249272 -
Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
|
Phase 4 | |
Recruiting |
NCT03846297 -
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
|
||
Completed |
NCT02806479 -
Hypertrophic Cardiomyopathy Pilot Study
|
||
Active, not recruiting |
NCT01225978 -
Refining Information Technology Support for Genetics in Medicine
|
N/A | |
Completed |
NCT00001632 -
Investigation Into the Use of Ultrasound Technique in the Evaluation of Heart Disease
|
N/A | |
Completed |
NCT00001534 -
Long Term Effects of Enalapril and Losartan on Genetic Heart Disease
|
N/A | |
Enrolling by invitation |
NCT04050579 -
OPIE in the Thin Interventricular Septum
|
N/A | |
Completed |
NCT03537183 -
Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy?
|
N/A | |
Completed |
NCT02590809 -
Hypertrophic Cardiomyopathy Symptom Release by BX1514M
|
Phase 2 | |
Completed |
NCT00001396 -
Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...
|
Phase 1 | |
Active, not recruiting |
NCT03723655 -
A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
|
Phase 2/Phase 3 | |
Completed |
NCT05135871 -
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
|
Phase 1 | |
Completed |
NCT04129905 -
Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
|
N/A | |
Recruiting |
NCT03061994 -
Metabolomic Study of All-age Cardiomyopathy
|
N/A | |
Completed |
NCT02234336 -
Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
|
||
Recruiting |
NCT00221832 -
Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
|
N/A | |
Not yet recruiting |
NCT03706001 -
Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
|
N/A | |
Recruiting |
NCT06169358 -
Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy
|
||
Not yet recruiting |
NCT04090437 -
HCM-AF Ablation With ACUTUS
|
N/A | |
Completed |
NCT04402268 -
Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy
|