Hypertrophic Cardiomyopathy Clinical Trial
— QUALIMYORYTHMOfficial title:
Healthy-related Quality of Life and Physical Activity of Children With Inherited Cardiac Arrhythmia or Inherited Cardiomyopathies: the Prospective Multicentre Controlled QUALIMYORYTHM Study
Verified date | May 2024 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 214 |
Est. completion date | June 20, 2023 |
Est. primary completion date | June 20, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Arnaud de Villeneuve | Montpellier | Occitanie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Hopital Lariboisière, Hôpital Necker-Enfants Malades, Hospices Civils de Lyon, Nantes University Hospital, Saint Pierre Institute - Palavas les Flots, University Hospital, Bordeaux, University Hospital, Toulouse |
France,
Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. 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. Health Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6. — View Citation
Souilla L, Avesani M, Boisson A, Requirand A, Matecki S, Vincenti M, Werner O, De La Villeon G, Pommier V, Pasquie JL, Guillaumont S, Amedro P. Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study. Front Cardiovasc Med. 2023 Jan 11;9:1081106. doi: 10.3389/fcvm.2022.1081106. eCollection 2022. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total score of health-reported quality of life self questionnaire | PedsQL questionnaire | baseline (1 day) | |
Secondary | The metabolic equivalent of task | measured by the wearable actimeter device. | during 14 days after inclusion | |
Secondary | physical activity level | Ricci and Gagnon questionnaire | baseline (1 day) | |
Secondary | Motivation towards health-oriented physical activity | EMAPS motivation scale | baseline (1 day) | |
Secondary | Exercise capacity | Cardiopulmonary exercise test with VO2max assessment | baseline (1 day) | |
Secondary | Myocardial morphologic assessment | cardiac MRI | baseline (1 day) |
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
|