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Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MacNew questionnaire
Sponsored by
Pierre Wauthy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Congenital Heart Disease focused on measuring MacNew questionnaire, Quality of life

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

None

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Congenital cardiopathy

Arm Description

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.

Outcomes

Primary Outcome Measures

MacNew questionnaire
Quality of life assessment

Secondary Outcome Measures

Full Information

First Posted
February 8, 2017
Last Updated
November 20, 2017
Sponsor
Pierre Wauthy
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1. Study Identification

Unique Protocol Identification Number
NCT03050112
Brief Title
Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.
Official Title
Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pierre Wauthy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
MacNew questionnaire, Quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Congenital cardiopathy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MacNew questionnaire
Intervention Description
Patients will be asked to fill in the MacNew questionnaire on quality of life (phone contact).
Primary Outcome Measure Information:
Title
MacNew questionnaire
Description
Quality of life assessment
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halit Ozel
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Wauthy, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Study Director
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20923595
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.
Results Reference
background
PubMed Identifier
12067950
Citation
Lane DA, Lip GY, Millane TA. Quality of life in adults with congenital heart disease. Heart. 2002 Jul;88(1):71-5. doi: 10.1136/heart.88.1.71.
Results Reference
background
PubMed Identifier
15785299
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. doi: 10.1097/01.hjr.0000159318.62466.dc.
Results Reference
background
PubMed Identifier
23388149
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.
Results Reference
background
PubMed Identifier
23955787
Citation
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.
Results Reference
background
PubMed Identifier
14713315
Citation
Hofer 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. doi: 10.1186/1477-7525-2-3.
Results Reference
background
PubMed Identifier
25453715
Citation
Pavy B, Iliou MC, Hofer S, Verges-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.
Results Reference
background
PubMed Identifier
12018740
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. doi: 10.1023/a:1015005109731.
Results Reference
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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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