Contribution of Echocardiography to Prognostic Evaluation of Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Contribution of Echocardiography to Prognostic Evaluation of Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885155
• Other study ID #: 2006CPRC/CHABOT
• Status: Completed
• Phase: N/A
• First received: August 26, 2016
• Last updated: August 26, 2016
• Start date: January 2007
• Est. completion date: January 2012

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Other:
• Echocardiography
planned at regular intervals
• Hemodynamic examinations (right cardiac catheterization)
planned at regular intervals

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at 5 years		5 years	No