Cardiac Repercussion of Systemic Sclerodermias (HTAP-SCLERO)
Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension (PAHT).
In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the other hand, the tracking and the analysis of its effects on the right ventricular function are difficult with the conventional techniques.
So, the analysis of the right ventricular function appears capital, because:
- it is recognized like an essential determinant of the symptoms and effort capacity,
- its prevalence, physiopathology and prognostic values remain unknown in this pathology,
- its interest in the starting of the treatment remains to be specified.
The aim of this trial is to identify in a population of 150 patients presenting a systemic scleroderma without PAHT:
- the incidence of a right ventricular dysfonction, evaluated by the analysis of the myocardic regional function with myocardial tissular Doppler mode,
- the physiopathology of this damage by correlation with the tests of respiratory function and the not invasive hemodynamic datas at rest and exercise.
- the prognosis value of the abnormalities of the right ventricular function by a follow-up of these patients over a 5 years period.
This trial should allowed to define the place of the new right ventricular function markers in the evaluation of the functional consequences, the forecast and perhaps the care of systemic sclerodermic patients.
|Systemic Scleroderma||Procedure: Echocardiography with myocardial tissular Doppler mode|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Cardiac Repercussion of Systemic Sclerodermias : Detection of Infra-clinical Abnormalities by Analysis of the Myocardic Regional Function Using Myocardial Tissular Doppler Mode.|
- To measure the incidence of right ventricular dysfonction evaluated by analysis of the regional myocardic function with myocardial tissular Doppler mode [ Time Frame: each year for 5 years ]
- To define the potential place of new regional myocardic function markers in the evaluation of the cardiac repercussion of systemic scleroderma and to correlate these markers with clinical, functional and hemodynamic parameters. [ Time Frame: each year for five years ]
- To detect an eventual prognostic role of regional myocardic function parameters which could allow to an earlier screening of the patients being able to receive a pulmonary vasodilator treatment before the rest PAHT occurrence . [ Time Frame: each year for five years ]
|Study Start Date:||March 2007|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Procedure: Echocardiography with myocardial tissular Doppler mode
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697736
|Hôpital Louis Pradel|
|BRON Cedex, France, 69 677|