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| Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00434902 |
Purpose
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 |
|---|
|
Sickle Cell Disease |
| Study Type: | Observational |
| Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Evaluation of the Characteristics, Prevalence and Prognosis of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease: Study ETENDARD. |
| Estimated Enrollment: | 700 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | June 2011 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Florence Parent, MD | 33 (0) 1 45 37 40 46 | florence.parent@abc.aphp.fr |
| France | |
| Hôpital Antoine Béclère | Recruiting |
| Clamart, France, 92141 | |
| Contact: Florence PARENT, MD 33 (0) 1 45 37 40 46 florence.parent@abc.aphp.fr | |
| Principal Investigator: Gerald SIMONNEAU, MD | |
| 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
| Study ID Numbers: | PO51082, AOM-05037 |
| Study First Received: | February 13, 2007 |
| Last Updated: | August 10, 2007 |
| ClinicalTrials.gov Identifier: | NCT00434902 |
| Health Authority: | France: Ministry of Health |
|
Doppler Echocardiography Pulmonary hypertension Sickle cell disease |
|
Hematologic Diseases Anemia Vascular Diseases Anemia, Hemolytic Sickle cell anemia Anemia, Hemolytic, Congenital Genetic Diseases, Inborn |
Respiratory Tract Diseases Hypertension, Pulmonary Hemoglobinopathies Lung Diseases Hemoglobinopathy Anemia, Sickle Cell Hypertension |
|
Cardiovascular Diseases |
