Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02885155
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2016-08-26
Brief Title:
Contribution of Echocardiography to Prognostic Evaluation of Pulmonary Arterial Hypertension
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Contribution of Echocardiography to Prognostic Evaluation of Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to determine the prognostic value of echocardiographic parameters in comparison with clinical and hemodynamic parameters in pulmonary arterial hypertension PAH
A secondary purpose of this study is to analyze the disease evolution after 3 to 6 months In pulmonary fibrosis it has been demonstrated that the variation of clinical and paraclinical parameters between 2 examinations has a prognostic interest In this study the prognostic value of variation of some echocardiographic parameters between initial examination and echocardiography after 3 or 6 months will be evaluated
Another secondary purpose is to create a common database for Pneumology Cardiology and Epidemiology departments with prospective registration of new cases of PAH and follow of patients under treatment
A secondary purpose of this study is to analyze the disease evolution after 3 to 6 months In pulmonary fibrosis it has been demonstrated that the variation of clinical and paraclinical parameters between 2 examinations has a prognostic interest In this study the prognostic value of variation of some echocardiographic parameters between initial examination and echocardiography after 3 or 6 months will be evaluated
Another secondary purpose is to create a common database for Pneumology Cardiology and Epidemiology departments with prospective registration of new cases of PAH and follow of patients under treatment
Detailed Description:
Pulmonary arterial hypertension PAH is a rare pathology with a poor prognosis and a median survival lower than 3 years in the absence of a specific treatment
The prognostic evaluation is based on clinical and hemodynamic data needing the right cardiac catheterization It has been shown that prognosis depends essentially on the severity of right ventricular dysfunction Recently various echocardiographic parameters derived from new techniques such as tissue Doppler have been validated for the evaluation of right ventricular function Some have been used as prognostic factor in cardiac insufficiency but not in PAH
This is an observational retrospective and then prospective study Usual PAH assessment includes a complete clinical and paraclinical evaluation History and physical examination assess dyspnea search signs of disease severity and quantify functional impact of 6 min-walking test An echocardiography and a right cardiac catheterization are realized in all patients Clinical consultations of patients and control echocardiographic and hemodynamic examinations are programmed at regular intervals
The demonstration of prognostic value of some echocardiographic parameters could diminish right cardiac catheterizations
The prognostic evaluation is based on clinical and hemodynamic data needing the right cardiac catheterization It has been shown that prognosis depends essentially on the severity of right ventricular dysfunction Recently various echocardiographic parameters derived from new techniques such as tissue Doppler have been validated for the evaluation of right ventricular function Some have been used as prognostic factor in cardiac insufficiency but not in PAH
This is an observational retrospective and then prospective study Usual PAH assessment includes a complete clinical and paraclinical evaluation History and physical examination assess dyspnea search signs of disease severity and quantify functional impact of 6 min-walking test An echocardiography and a right cardiac catheterization are realized in all patients Clinical consultations of patients and control echocardiographic and hemodynamic examinations are programmed at regular intervals
The demonstration of prognostic value of some echocardiographic parameters could diminish right cardiac catheterizations
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