Northwest Adult Congenital Heart Disease Observatory (CARL)

Northwest Inter Hospital Adult Congenital Heart Disease Observatory

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.

Study Overview

• Status: Unknown
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: description

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Recruiting
    • Caen University Hospital
    • Contact: Fabien Labombarda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients characteristics description	Obtain epidemiological data on adult congenital of the population followed in northwest region of France	baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
heart disease complications description	baseline
complications during pregnancy description	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2016
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 14-140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED