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Northwest Adult Congenital Heart Disease Observatory (CARL)

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ClinicalTrials.gov Identifier: NCT02897323
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
The incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. The number of patients increases continuously as life expectancy increases. An increasing number of patients with complex heart defects survive to adulthood. The medico-surgical management of this highly specialized growing number of patients is difficult and requires a multidisciplinary collaboration. In France, an estimated 200,000 patients the number of carrier patients with congenital heart disease. Half of them will require monitoring, medical procedures, catheterizations and/or surgical re-intervention. No objective demographic data are currently available on the French patients. So, the investigators decided to set up an epidemiological project to better understand this cohort of patients. The main objective of this project is to obtain accurate epidemiological data needed to adapt the supply of care.

Condition or disease Intervention/treatment
Congenital Heart Disease Other: description

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Northwest Inter Hospital Adult Congenital Heart Disease Observatory
Actual Study Start Date : November 14, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. patients characteristics description [ Time Frame: baseline ]
    Obtain epidemiological data on adult congenital of the population followed in northwest region of France


Secondary Outcome Measures :
  1. heart disease complications description [ Time Frame: baseline ]
  2. complications during pregnancy description [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

consecutive patients visiting the participating centers meet the following criteria:

  • Patient, male or female, aged 18 years
  • with congenital heart disease operated or non-operated
  • Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France
Criteria

Inclusion Criteria:

  • Patient, male or female, aged 18 years
  • Congenital heart disease operated or non-operated
  • Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France

Exclusion Criteria:

  • Patient refusal

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): NCT02897323


Contacts
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Contact: Fabien Labombarda 0231064767 ext +33

Locations
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France
Caen University Hospital Recruiting
Caen, France
Contact: Fabien LABOMBARDA         
Sponsors and Collaborators
University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02897323     History of Changes
Other Study ID Numbers: 14-140
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities