Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.
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|ClinicalTrials.gov Identifier: NCT03050112|
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : November 22, 2017
Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome.
There is nowadays a growing interest in the quality of life of this group of subjects. However, studies give contradictory results. This can be explained on one hand by the vast majority of pathologies within this population, and on the other hand by the absence of a cardio-specific tool for quality of life measurement.
The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life based on the exploration of three domains: physical, emotional and social.
The aim of this study is:
- to evaluate the quality of life of these patients, by using the MacNew questionnaire
- to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up
- to assess the mortality within this group of patients.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease||Other: MacNew questionnaire||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.|
|Actual Study Start Date :||February 14, 2017|
|Actual Primary Completion Date :||June 1, 2017|
|Actual Study Completion Date :||June 1, 2017|
Experimental: Congenital cardiopathy
Patients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015.
Other: MacNew questionnaire
Patients will be asked to fill in the MacNew questionnaire on quality of life (phone contact).
- MacNew questionnaire [ Time Frame: 30 minutes ]Quality of life assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050112
|Brussels, Belgium, 1020|
|Principal Investigator:||Halit Ozel||CHU Brugmann|
|Study Director:||Pierre Wauthy, MD||CHU Brugmann|