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Observatory of Pulmonary Arterial Hypertension of Congenital Heart Disease (ItinerAir)

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ClinicalTrials.gov Identifier: NCT02260362
Recruitment Status : Recruiting
First Posted : October 9, 2014
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society

Brief Summary:

The complex congenital cardiac malformations are a significant number of different diseases, each having specific natural histories. The interface with pulmonary arterial hypertension (HTAP) is high since the physiology of many of these disorders comprises alterations in pulmonary vasculature.

This observatory is a cohort of 400 patients enrolled in 3 years, older than one month, having been informed and have agreed to participate in the study and with congenital heart disease other than patent foramen ovale as well as a diagnosis of pulmonary hypertension confirmed by cardiac catheterization.

The main objectives of this report are to know

  • Incidence of congenital heart disease in HTAP France.
  • Describe the natural history of HTAP in a large population of patients Congenital heart disease in France
  • The characteristics of HTAP congenital heart disease
  • Having a cohort study

Condition or disease
Pulmonary Arterial Hypertension of Congenital Heart Disease

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observatory of Pulmonary Arterial Hypertension of Congenital Heart Disease
Study Start Date : October 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2021


Group/Cohort
HTAP of Congenital Heart Disease



Primary Outcome Measures :
  1. Incidence HTAP of congenital heart disease in France. [ Time Frame: 3 years ]
    Number of HTAP of congenital heart disease in France after 3 years of inclusions



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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with Pulmonary Arterial Hypertension of Congenital Heart Disease supported by one of the 20 centers participating in the observatory during the period incusion and respecting al the selection criteria
Criteria

Inclusion Criteria:

  • The patient has a congenital heart disease other than patent foramen ovale
  • The diagnosis of pulmonary hypertension was confirmed by cardiac catheterization. Only patients with Eisenmenger syndrome can be included without catheterization.
  • The catheterization was done after 1 January 2009
  • A mean pulmonary artery pressure > 25 mm Hg
  • Pulmonary vascular resistances > 3 piece Wood m2
  • Pulmonary capillary pressure available
  • Consent for inclusion in the study must be signed by parents or legal guardians for minors, by the patient for adults.
  • The patient he had a surgical procedure or interventional catheterization cardiac catheterization between his diagnosis and inclusion in the observatory? If yes, it can only be included if a new catheterization confirmed the persistence of HTAP at least 6 months after the procedure.
  • Patient follow-up (at least once a year) in the center for its HTAP associated with congenital heart disease its

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): NCT02260362


Contacts
Contact: Damien Bonnet 33(0)144907028 itinerair@sfcardio.fr

Locations
France
Hopital Necker Enfants Malades Recruiting
Paris, France
Contact: Damien Bonnet         
Sponsors and Collaborators
French Cardiology Society

Publications:

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT02260362     History of Changes
Other Study ID Numbers: 14126
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Hypertension
Heart Diseases
Familial Primary Pulmonary Hypertension
Heart Defects, Congenital
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities