Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434902
Status:
UNKNOWN
Last Update Posted:
2012-12-19
First Post:
2007-02-13
Brief Title:
Evaluation of the Prevalence of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of the Characteristics Prevalence and Prognosis of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease Study ETENDARD
Status:
UNKNOWN
Status Verified Date:
2012-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETENDARD
Brief Summary:
Recent data show that pulmonary hypertension PH defined by a tricuspid regurgitation jet TRJ velocity or equal at 25ms 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 dynesThe 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
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 25ms 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOM-05037 | None | None | None |