- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01202916
Quality of Life Among Children With Congenital Heart Disease
March 5, 2021 updated by: University Hospital, Montpellier
Congenital heart diseases (CHD) are the first cause of congenital malformations with an incidence of 8 for 1000 births.
Within the two past decades prenatal diagnosis has had a great impact on CHD prevalence.
France was the first country to show the impact of prenatal diagnosis on the lowering prevalence of the most severe CHD, the hypoplastic left heart syndrome.
Since the 90's, great advances in pediatric cardiac surgery, intensive care and cardiac catheterization have led to lower mortality and morbidity in this population.
Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly increasing.
For all these reasons and as the investigators can also see in other many chronic diseases, new questions about the quality of life of these patients arise among patients, parents/future parents, doctors, patients associations, and public health organizations.
In 2007 French government promoted a national public health plan for "improvement of the quality of life among patients suffering from chronic illnesses".
First step of such a program is to correctly evaluate this quality of life.
Indeed the concept of "quality of life" (QoL) remains subjective and difficult to appreciate and measure.
Its analysis requires the use of validated questionnaires.
Few questionnaires are available in Europe, especially in pediatrics.
Few studies in this population have been led and no comparative study to a control randomized group has been published.
The investigators study aims to analyze in the investigators tertiary care center in pediatric cardiology the QoL among 8 to 18 year old French patients with CHD using a validated questionnaire (Kidscreen™) and to compare it to same aged healthy children.
The investigators secondarily intend to :- validate the French version of one reference pediatric QoL questionnaire used in most publications in the USA (PedsQL™).
- compare the QoL to the severity of the CHD using a published semi-quantitative score.-
compare the QoL to the severity of the CHD using the results of routine exercise tests (VO2 max) performed routinely in the investigators center.
The investigators hypothesis are that :- Quality of life of most common and not severe CHD is close to that of healthy children.
- QoL of severe CHD is not so well correlated to severity of CHD.- PedsQL™ is a simple questionnaire which can be used in France in routine follow-up of children with CHD.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
316
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montpellier, France, 34295
- Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- children with congenital heart disease
- healthy children
Description
Inclusion Criteria:
- patients with congenital heart disease (defined by Chapter Q of the ICD-10)
- Patient participation in the study noted in the medical record.Exclusion Criteria:
- Age greater than or equal to 8 years and less than 18 years
- Whose parents signed written consent
- Obligation of membership or beneficiary of a French social security
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy children
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Congenital Heart Disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Quality of Life questionnaire
Time Frame: one day
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one day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: AMEDRO Pascal, MD, PhD, UH Montpellier
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Amedro P, Tahhan N, Bertet H, Jeandel C, Guillaumont S, Mura T, Picot MC. Health-related quality of life among children with Turner syndrome: controlled cross-sectional study. J Pediatr Endocrinol Metab. 2017 Aug 28;30(8):863-868. doi: 10.1515/jpem-2017-0026.
- Amedro P, Bajolle F, Bertet H, Cheurfi R, Lasne D, Nogue E, Auquier P, Picot MC, Bonnet D. Quality of life in children participating in a non-selective INR self-monitoring VKA-education programme. Arch Cardiovasc Dis. 2018 Mar;111(3):180-188. doi: 10.1016/j.acvd.2017.05.013. Epub 2017 Nov 1.
- Amedro P, Dorka R, Moniotte S, Guillaumont S, Fraisse A, Kreitmann B, Borm B, Bertet H, Barrea C, Ovaert C, Sluysmans T, De La Villeon G, Vincenti M, Voisin M, Auquier P, Picot MC. Quality of Life of Children with Congenital Heart Diseases: A Multicenter Controlled Cross-Sectional Study. Pediatr Cardiol. 2015 Dec;36(8):1588-601. doi: 10.1007/s00246-015-1201-x. Epub 2015 May 31.
- Gavotto A, Vandenberghe D, Abassi H, Huguet H, Macioce V, Picot MC, Guillaumont S, Matecki S, Amedro P. Oxygen uptake efficiency slope: a reliable surrogate parameter for exercise capacity in healthy and cardiac children? Arch Dis Child. 2020 Dec;105(12):1167-1174. doi: 10.1136/archdischild-2019-317724. Epub 2020 Jul 30.
- Amedro P, Gavotto A, Guillaumont S, Bertet H, Vincenti M, De La Villeon G, Bredy C, Acar P, Ovaert C, Picot MC, Matecki S. Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart. 2018 Jun;104(12):1026-1036. doi: 10.1136/heartjnl-2017-312339. Epub 2017 Nov 23.
- Abassi H, Gavotto A, Picot MC, Bertet H, Matecki S, Guillaumont S, Moniotte S, Auquier P, Moreau J, Amedro P. Impaired pulmonary function and its association with clinical outcomes, exercise capacity and quality of life in children with congenital heart disease. Int J Cardiol. 2019 Jun 15;285:86-92. doi: 10.1016/j.ijcard.2019.02.069. Epub 2019 Mar 1.
- Gavotto A, Huguet H, Picot MC, Guillaumont S, Matecki S, Amedro P. The V̇e/V̇co2 slope: a useful tool to evaluate the physiological status of children with congenital heart disease. J Appl Physiol (1985). 2020 Nov 1;129(5):1102-1110. doi: 10.1152/japplphysiol.00520.2020. Epub 2020 Sep 10.
- Amedro P, Huguet H, Macioce V, Dorka R, Auer A, Guillaumont S, Auquier P, Abassi H, Picot MC. Psychometric validation of the French self and proxy versions of the PedsQL 4.0 generic health-related quality of life questionnaire for 8-12 year-old children. Health Qual Life Outcomes. 2021 Mar 4;19(1):75. doi: 10.1186/s12955-021-01714-y.
- Amedro P, Picot MC, Moniotte S, Dorka R, Bertet H, Guillaumont S, Barrea C, Vincenti M, De La Villeon G, Bredy C, Soulatges C, Voisin M, Matecki S, Auquier P. Correlation between cardio-pulmonary exercise test variables and health-related quality of life among children with congenital heart diseases. Int J Cardiol. 2016 Jan 15;203:1052-60. doi: 10.1016/j.ijcard.2015.11.028. Epub 2015 Nov 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (ACTUAL)
September 1, 2011
Study Completion (ACTUAL)
September 1, 2011
Study Registration Dates
First Submitted
September 14, 2010
First Submitted That Met QC Criteria
September 15, 2010
First Posted (ESTIMATE)
September 16, 2010
Study Record Updates
Last Update Posted (ACTUAL)
March 9, 2021
Last Update Submitted That Met QC Criteria
March 5, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8422
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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