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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03050112
Other study ID # CHUB-QOL cardiopathy
Secondary ID
Status Completed
Phase N/A
First received February 8, 2017
Last updated November 20, 2017
Start date February 14, 2017
Est. completion date June 1, 2017

Study information

Verified date November 2017
Source Brugmann University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date June 1, 2017
Est. primary completion date June 1, 2017
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Intervention

Other:
MacNew questionnaire
Patients will be asked to fill in the MacNew questionnaire on quality of life (phone contact).

Locations

Country Name City State
Belgium CHU Brugmann Brussels

Sponsors (1)

Lead Sponsor Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

References & Publications (8)

Apers S, Luyckx K, Moons P. Quality of life in adult congenital heart disease: what do we already know and what do we still need to know? Curr Cardiol Rep. 2013 Oct;15(10):407. doi: 10.1007/s11886-013-0407-x. Review. — View Citation

Dixon T, Lim LL, Oldridge NB. The MacNew heart disease health-related quality of life instrument: reference data for users. Qual Life Res. 2002 Mar;11(2):173-83. — View Citation

Fteropoulli T, Stygall J, Cullen S, Deanfield J, Newman SP. Quality of life of adult congenital heart disease patients: a systematic review of the literature. Cardiol Young. 2013 Aug;23(4):473-85. doi: 10.1017/S1047951112002351. Epub 2013 Feb 6. Review. — View Citation

Höfer S, Lim L, Guyatt G, Oldridge N. The MacNew Heart Disease health-related quality of life instrument: a summary. Health Qual Life Outcomes. 2004 Jan 8;2:3. — View Citation

Immer FF, Althaus SM, Berdat PA, Saner H, Carrel TP. Quality of life and specific problems after cardiac surgery in adolescents and adults with congenital heart diseases. Eur J Cardiovasc Prev Rehabil. 2005 Apr;12(2):138-43. — View Citation

Lane DA, Lip GY, Millane TA. Quality of life in adults with congenital heart disease. Heart. 2002 Jul;88(1):71-5. — View Citation

Pavy B, Iliou MC, Höfer S, Vergès-Patois B, Corone S, Aeberhard P, Curnier D, Henry J, Ponchon-Weess A, Oldridge N. Validation of the French version of the MacNew heart disease health-related quality of life questionnaire. Arch Cardiovasc Dis. 2015 Feb;108(2):107-17. doi: 10.1016/j.acvd.2014.09.006. Epub 2014 Nov 12. — View Citation

Wauthy P, Massaut J, Sanoussi A, Demanet H, Morissens M, Damry N, Dessy H, Malekzadeh-Milani SG, Deuvaert FE. Ten-year experience with surgical treatment of adults with congenital cardiac disease. Cardiol Young. 2011 Feb;21(1):39-45. doi: 10.1017/S1047951110001332. Epub 2010 Oct 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary MacNew questionnaire Quality of life assessment 30 minutes
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