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OpenTrials
Completed

NCT Number: NCT03050112

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MacNew questionnaire

Other

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

Primary outcomes

  1. MacNew questionnaire

    Time frame: 30 minutes

    Quality of life assessment

Sponsors and collaborators

Lead sponsor

Pierre Wauthy

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2017
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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