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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050112
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Pierre Wauthy, Brugmann University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Other: MacNew questionnaire Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. MacNew questionnaire [ Time Frame: 30 minutes ]
    Quality of life assessment


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Pierre Wauthy
Investigators
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Principal Investigator: Halit Ozel CHU Brugmann
Study Director: Pierre Wauthy, MD CHU Brugmann
More Information
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Publications:

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Responsible Party: Pierre Wauthy, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03050112    
Other Study ID Numbers: CHUB-QOL cardiopathy
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierre Wauthy, Brugmann University Hospital:
MacNew questionnaire
Quality of life
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities