Evaluation of the Prevalence of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease (ETENDARD)
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|ClinicalTrials.gov Identifier: NCT00434902|
Recruitment Status : Unknown
Verified November 2012 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : February 14, 2007
Last Update Posted : December 19, 2012
|Condition or disease|
|Sickle Cell Disease|
Consecutive adult patients with sickle cell disease (SCD) had a Doppler echocardiography to evaluate if they had a suspected pulmonary hypertension (PH) on the basis of a tricuspid regurgitation jet (TRJ) velocity > or equal at 2.5m/s. In this case, a right heart catheterization was performed to confirm or not this diagnosis and its mechanisms. Each included patient was followed every year for 3 years: during each visit, a clinical evaluation was obtained and a Doppler echocardiography. In case of emergence of a suspected PH, a right heart catheterization was performed to confirm or not this diagnosis and its mechanisms.
Three groups of patients were defined: no PH, precapillary PH, and a third group including post-capillary PH and hyperkinetic state. These groups were well defined on the basis of the results of th Doppler echocardiography and right heart catheterisation.
Characteristics of patients and their prognosis were evaluated in each group.
In the same, way, biological study is planned to evaluate some biological markers of the mechanism of PH, and prognostic factors.
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Evaluation of the Characteristics, Prevalence and Prognosis of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease: Study ETENDARD.|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||March 2009|
|Estimated Study Completion Date :||December 2012|
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): NCT00434902
|Hôpital Antoine Béclère|
|Clamart, France, 92141|
|Principal Investigator:||Gerald SIMONNEAU, MD||Hôpital Antoine Béclère, CLAMART|
|Principal Investigator:||Frederic Galacteros, MD||Hôpital Henri Mondor, Creteil|
|Study Director:||Serge ADNOT, MD||Hôpital Henri Mondor, CRETEIL|
|Study Director:||Bernard MAITRE, MD||Hopital Henri Mondor, CRETEIL|
|Study Director:||Marc HUMBERT, MD||Hôpîtal Antoine Béclere, CLAMART|
|Study Director:||Robert GIROT, MD||Hôpital Tenon, PARIS|
|Study Director:||François LIONNET, MD||Hôpital TENON, PARIS|
|Study Director:||Françoise DRISS, MD||Hôpital Bicêtre, KREMLIN BICETRE|
|Study Chair:||Olivier LAMBOTTE, MD||Hôpital Bicêtre, KREMLIN BICETRE|
|Study Director:||Jocelyn INAMO, MD||CHU Fort de France|
|Study Director:||Gylna LOKO, MD||CHU Fort de France|
|Study Director:||Olivier SITBON, MD||Hôpital Antoine Béclère, CLAMART|
|Study Director:||Xavier Jaïs, MD||Hôpital Antoine Béclère, CLAMART|
|Study Chair:||Anoosha Habibi, MD||Hôpital Henri Mondor, CRETEIL|
|Study Chair:||Dora Bachir, MD||Hôpital Henri Mondor, CRETEIL|
|Study Chair:||Laurent SAVALE, MD||Hopital Henri Mondor, CRETEIL|
|Study Chair:||Saadia Eddahibi, MD||Hôpital Henri Mondor, CRETEIL|
|Study Chair:||Gilles Garcia, MD||Hopital Antoine Béclère, CLAMART|