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

Primary Purpose

Long QT Syndrome, Brugada Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MRI

About this trial

This is an interventional other trial for Long QT Syndrome focused on measuring Life quality, Physical activity, Paediatric cardiology, Inherited cardiac arrhythmia, Genetic cardiomyopathies

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

CHU Arnaud de VilleneuveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cardiac disease

Control group

Arm Description

Children aged of 6 to 18 years old 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).

Children aged 6 to 18 years old referred to the paediatric cardiology consultation who were classified in the control group after a completely normal check-up, including physical examination, electrocardiogram, and echocardiography.

Outcomes

Primary Outcome Measures

Total score of health-reported quality of life self questionnaire

PedsQL questionnaire

Secondary Outcome Measures

The metabolic equivalent of task

measured by the wearable actimeter device.

physical activity level

Ricci and Gagnon questionnaire

Motivation towards health-oriented physical activity

EMAPS motivation scale

Exercise capacity

Cardiopulmonary exercise test with VO2max assessment

Myocardial morphologic assessment

cardiac MRI

Full Information

NCT ID

NCT04712136

First Posted

January 14, 2021

Last Updated

January 30, 2023

Sponsor

University Hospital, Montpellier

Collaborators

Saint Pierre Institute - Palavas les Flots, University Hospital, Toulouse, University Hospital, Bordeaux, Hôpital Necker-Enfants Malades, Hopital Lariboisière, Nantes University Hospital, Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT04712136

Brief Title

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

Acronym

QUALIMYORYTHM

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Long QT Syndrome, Brugada Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia, Arrhythmogenic Right Ventricular Dysplasia, Hypertrophic Cardiomyopathy, Dilated Cardiomyopathy, Restrictive Cardiomyopathy

Keywords

Life quality, Physical activity, Paediatric cardiology, Inherited cardiac arrhythmia, Genetic cardiomyopathies

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cardiac disease

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

MRI

Intervention Description

MRI cardiac

Primary Outcome Measure Information:

Title

Total score of health-reported quality of life self questionnaire

Description

PedsQL questionnaire

Time Frame

baseline (1 day)

Secondary Outcome Measure Information:

Title

The metabolic equivalent of task

Description

measured by the wearable actimeter device.

Time Frame

during 14 days after inclusion

Title

physical activity level

Description

Ricci and Gagnon questionnaire

Time Frame

baseline (1 day)

Title

Motivation towards health-oriented physical activity

Description

EMAPS motivation scale

Time Frame

baseline (1 day)

Title

Exercise capacity

Description

Cardiopulmonary exercise test with VO2max assessment

Time Frame

baseline (1 day)

Title

Myocardial morphologic assessment

Description

cardiac MRI

Time Frame

baseline (1 day)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pascal AMEDRO, MD

Phone

0467336632

p-amedro@chu-montpellier.fr

Facility Information:

Facility Name

CHU Arnaud de Villeneuve

City

Montpellier

State/Province

Occitanie

ZIP/Postal Code

34090

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal AMEDRO, PhD

Phone

+33 (0) 4 67 33 66 39

p-amedro@chu-montpellier.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

34321045

Citation

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.

Results Reference

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PubMed Identifier

36712265

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.

Results Reference

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

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