Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT00434902
Status:
UNKNOWN
Last Update Posted:
2012-12-19
First Post:
2007-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Prevalence of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-18', 'studyFirstSubmitDate': '2007-02-13', 'studyFirstSubmitQcDate': '2007-02-13', 'lastUpdatePostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Doppler Echocardiography', 'Pulmonary hypertension', 'Sickle cell disease'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '15194173', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11907289', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15459304', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12969866', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10807826', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '40693500', 'type': 'DERIVED', 'citation': "Simon T, Savale L, Grundtvig Skaarup K, Breillat P, Pham LL, Nouraie SM, Dyrby Johansen N, Inamo J, Lionnet F, Loko G, Chantalat C, Pham Hung d'Alexandry d'Orengiani AL, Habibi A, de Luna G, Iles S, Galacteros F, Audureau E, Biering-Sorensen T, Bartolucci P, Derumeaux G, d'Humieres T. Sickle Cell Diastolic Cardiomyopathy and Mortality Risk: A Novel Echocardiographic Framework for Prognostic Stratification. Am J Hematol. 2025 Nov;100(11):1940-1951. doi: 10.1002/ajh.27768. Epub 2025 Jul 22."}, {'pmid': '21732836', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThree 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.\n\nCharacteristics of patients and their prognosis were evaluated in each group.\n\nIn the same, way, biological study is planned to evaluate some biological markers of the mechanism of PH, and prognostic factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Patients With Sickle Cell Disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Homozygous SS sickle cell disease\n* Male or female \\> 18 years of age\n* VOC (Vaso-Occlusive crisis) or ACS (Acute chest syndrome)within 6 weeks of inclusion ("Stable state")\n* Signed written Informed consent\n\nExclusion Criteria:\n\n* Creatinine clearance \\< 30 ml/mn\n* prothrombin ratio \\< 50%\n* Severe pneumopathy and TLC (Total lung capacity) \\< 70%'}, 'identificationModule': {'nctId': 'NCT00434902', 'acronym': 'ETENDARD', 'briefTitle': 'Evaluation of the Prevalence of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of the Characteristics, Prevalence and Prognosis of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease: Study ETENDARD.', 'orgStudyIdInfo': {'id': 'PO51082'}, 'secondaryIdInfos': [{'id': 'AOM-05037'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'Hôpital Antoine Béclère', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}], 'overallOfficials': [{'name': 'Gerald SIMONNEAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Antoine Béclère, CLAMART'}, {'name': 'Frederic Galacteros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Henri Mondor, Creteil'}, {'name': 'Serge ADNOT, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Henri Mondor, CRETEIL'}, {'name': 'Bernard MAITRE, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hopital Henri Mondor, CRETEIL'}, {'name': 'Marc HUMBERT, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpîtal Antoine Béclere, CLAMART'}, {'name': 'Robert GIROT, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Tenon, PARIS'}, {'name': 'François LIONNET, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital TENON, PARIS'}, {'name': 'Françoise DRISS, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Bicêtre, KREMLIN BICETRE'}, {'name': 'Olivier LAMBOTTE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Bicêtre, KREMLIN BICETRE'}, {'name': 'Jocelyn INAMO, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Fort de France'}, {'name': 'Gylna LOKO, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Fort de France'}, {'name': 'Olivier SITBON, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Antoine Béclère, CLAMART'}, {'name': 'Xavier Jaïs, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Antoine Béclère, CLAMART'}, {'name': 'Anoosha Habibi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Henri Mondor, CRETEIL'}, {'name': 'Dora Bachir, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Henri Mondor, CRETEIL'}, {'name': 'Laurent SAVALE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Henri Mondor, CRETEIL'}, {'name': 'Saadia Eddahibi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Henri Mondor, CRETEIL'}, {'name': 'Gilles Garcia, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Antoine Béclère, CLAMART'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}