Northwest Adult Congenital Heart Disease Observatory

NCT02897323 | Unknown

• 1 other identifier: 14-140
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• patients characteristics description

  Obtain epidemiological data on adult congenital of the population followed in northwest region of France

  baseline

Secondary Outcomes (2)

• heart disease complications description

  baseline

• complications during pregnancy description

  baseline

Interventions

description OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patient refusal

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Fabien Labombarda

CONTACT

0231064767

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 13, 2016
• Study Start: November 14, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

FR (1)