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

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Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

Study Description

Brief Summary:

Recent data show that pulmonary hypertension (PH), defined by a tricuspid regurgitation jet (TRJ) velocity > or equal at 2.5m/s on Doppler echocardiography, is present in about 30% of adults with sickle cell disease (SCD) and is associated with poor prognosis. However in SCD the occurrence of PH (defined by mean pulmonary arterial pressure (mPAP)> or equal at 25 mmHg) is related to at least 3 mechanisms: PH due to hyperkinetic state with high cardiac output (CO) but normal pulmonary vascular resistance (PVR <160 dynes), or postcapillary PH (pulmonary capillary wedge pressure PCWP >15 mmHg), or precapillary pulmonary arterial hypertension (PAH) defined by mPAP > or equal at 25 mmHg, PCWP< or equal at 15 mmHg and PVR > or equal at 160 dynes.The aim of this study is to evaluate in a French population of adults with sickle cell disease the characteristics, prevalence and prognosis of pulmonary hypertension.

Condition or disease
Sickle Cell Disease

Detailed Description:

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 Design

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Study Type :	Observational
Estimated Enrollment :	700 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension Sickle cell disease

MedlinePlus related topics: Pulmonary Hypertension

Genetic and Rare Diseases Information Center resources: Sickle Cell Anemia

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult Patients With Sickle Cell Disease

Criteria

Inclusion Criteria:

Homozygous SS sickle cell disease
Male or female > 18 years of age
VOC (Vaso-Occlusive crisis) or ACS (Acute chest syndrome)within 6 weeks of inclusion ("Stable state")
Signed written Informed consent

Exclusion Criteria:

Creatinine clearance < 30 ml/mn
prothrombin ratio < 50%
Severe pneumopathy and TLC (Total lung capacity) < 70%

Contacts and Locations

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): NCT00434902

Locations

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France
Hôpital Antoine Béclère
Clamart, France, 92141

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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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

More Information

Publications:

Simonneau G, Galie N, Rubin LJ, Langleben D, Seeger W, Domenighetti G, Gibbs S, Lebrec D, Speich R, Beghetti M, Rich S, Fishman A. Clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2004 Jun 16;43(12 Suppl S):5S-12S. doi: 10.1016/j.jacc.2004.02.037.

Rubin LJ, Badesch DB, Barst RJ, Galie N, Black CM, Keogh A, Pulido T, Frost A, Roux S, Leconte I, Landzberg M, Simonneau G. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002 Mar 21;346(12):896-903. doi: 10.1056/NEJMoa012212. Erratum In: N Engl J Med 2002 Apr 18;346(16):1258.

Humbert M, Sitbon O, Simonneau G. Treatment of pulmonary arterial hypertension. N Engl J Med. 2004 Sep 30;351(14):1425-36. doi: 10.1056/NEJMra040291. No abstract available.

Lechapt E, Habibi A, Bachir D, Galacteros F, Schaeffer A, Desvaux D, Brochard L, Housset B, Godeau B, Maitre B. Induced sputum versus bronchoalveolar lavage during acute chest syndrome in sickle cell disease. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1373-7. doi: 10.1164/rccm.200302-174OC. Epub 2003 Sep 11.

Maitre B, Habibi A, Roudot-Thoraval F, Bachir D, Belghiti DD, Galacteros F, Godeau B. Acute chest syndrome in adults with sickle cell disease. Chest. 2000 May;117(5):1386-92. doi: 10.1378/chest.117.5.1386.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Parent F, Bachir D, Inamo J, Lionnet F, Driss F, Loko G, Habibi A, Bennani S, Savale L, Adnot S, Maitre B, Yaici A, Hajji L, O'Callaghan DS, Clerson P, Girot R, Galacteros F, Simonneau G. A hemodynamic study of pulmonary hypertension in sickle cell disease. N Engl J Med. 2011 Jul 7;365(1):44-53. doi: 10.1056/NEJMoa1005565.

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Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00434902
Other Study ID Numbers:	PO51082 AOM-05037
First Posted:	February 14, 2007 Key Record Dates
Last Update Posted:	December 19, 2012
Last Verified:	November 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:


Doppler Echocardiography Pulmonary hypertension Sickle cell disease

Additional relevant MeSH terms:

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Hypertension, Pulmonary Hypertension Anemia, Sickle Cell Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases	Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn

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