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Clinical Trials/NCT02885155
NCT02885155
Completed
Not Applicable

Contribution of Echocardiography to Prognostic Evaluation of Pulmonary Arterial Hypertension

Central Hospital, Nancy, France0 sites50 target enrollmentJanuary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
Central Hospital, Nancy, France
Enrollment
50
Primary Endpoint
Mortality at 5 years
Status
Completed
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
January 2012
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Mean pulmonary artery pressure \> 25 mmHg in hemodynamics
  • according to Venice classification: Idiopathic PAH or associated to other known risk factors (anorectics, portal hypertension, connective tissue diseases, in particular scleroderma but also lupus, congenital heart disease with Eisenmenger syndrome, HIV infection)

Exclusion Criteria

  • Atrial fibrillation
  • Poor echogenicity
  • PAH associated to another factor, thromboembolic disease, respiratory insufficiency, left heart disease or mitral or aortic valvulopathy

Outcomes

Primary Outcomes

Mortality at 5 years

Time Frame: 5 years

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