Observatory of Pulmonary Arterial Hypertension of Congenital Heart Disease
NCT ID: NCT02260362
Last Updated: 2022-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
349 participants
OBSERVATIONAL
2014-10-31
2022-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HTAP of Congenital Heart Disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
1 Month
ALL
No
Sponsors
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French Cardiology Society
OTHER
Responsible Party
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Locations
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Hopital Necker Enfants Malades
Paris, , France
Countries
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References
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Berger RM, Beghetti M, Humpl T, Raskob GE, Ivy DD, Jing ZC, Bonnet D, Schulze-Neick I, Barst RJ. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet. 2012 Feb 11;379(9815):537-46. doi: 10.1016/S0140-6736(11)61621-8. Epub 2012 Jan 11.
Barst RJ, McGoon MD, Elliott CG, Foreman AJ, Miller DP, Ivy DD. Survival in childhood pulmonary arterial hypertension: insights from the registry to evaluate early and long-term pulmonary arterial hypertension disease management. Circulation. 2012 Jan 3;125(1):113-22. doi: 10.1161/CIRCULATIONAHA.111.026591. Epub 2011 Nov 15.
Barst RJ, Ivy DD, Foreman AJ, McGoon MD, Rosenzweig EB. Four- and seven-year outcomes of patients with congenital heart disease-associated pulmonary arterial hypertension (from the REVEAL Registry). Am J Cardiol. 2014 Jan 1;113(1):147-55. doi: 10.1016/j.amjcard.2013.09.032. Epub 2013 Oct 4.
Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaici A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Simonneau G. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med. 2006 May 1;173(9):1023-30. doi: 10.1164/rccm.200510-1668OC. Epub 2006 Feb 2.
Fraisse A, Jais X, Schleich JM, di Filippo S, Maragnes P, Beghetti M, Gressin V, Voisin M, Dauphin C, Clerson P, Godart F, Bonnet D. Characteristics and prospective 2-year follow-up of children with pulmonary arterial hypertension in France. Arch Cardiovasc Dis. 2010 Feb;103(2):66-74. doi: 10.1016/j.acvd.2009.12.001. Epub 2010 Feb 11.
van Loon RL, Roofthooft MT, Hillege HL, ten Harkel AD, van Osch-Gevers M, Delhaas T, Kapusta L, Strengers JL, Rammeloo L, Clur SA, Mulder BJ, Berger RM. Pediatric pulmonary hypertension in the Netherlands: epidemiology and characterization during the period 1991 to 2005. Circulation. 2011 Oct 18;124(16):1755-64. doi: 10.1161/CIRCULATIONAHA.110.969584. Epub 2011 Sep 26.
Duffels MG, Engelfriet PM, Berger RM, van Loon RL, Hoendermis E, Vriend JW, van der Velde ET, Bresser P, Mulder BJ. Pulmonary arterial hypertension in congenital heart disease: an epidemiologic perspective from a Dutch registry. Int J Cardiol. 2007 Aug 21;120(2):198-204. doi: 10.1016/j.ijcard.2006.09.017. Epub 2006 Dec 19.
Other Identifiers
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14126
Identifier Type: -
Identifier Source: org_study_id
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