Cardiac Repercussion of Systemic Sclerodermias (HTAP-SCLERO)
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|ClinicalTrials.gov Identifier: NCT00697736|
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : November 13, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Scleroderma||Procedure: Echocardiography with myocardial tissular Doppler mode||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiac Repercussion of Systemic Sclerodermias : Detection of Infra-clinical Abnormalities by Analysis of the Myocardic Regional Function Using Myocardial Tissular Doppler Mode.|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
- Procedure: Echocardiography with myocardial tissular Doppler mode
Echocardiography with myocardial tissular Doppler mode during rest and exercise on a table equipped with a cyclo-ergometer
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697736
|Hôpital Louis Pradel|
|BRON Cedex, France, 69 677|