Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01202045|
Recruitment Status : Withdrawn
First Posted : September 15, 2010
Last Update Posted : July 8, 2013
|Condition or disease|
|Scleroderma, Systemic Hypertension, Pulmonary|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients With Indirect Signs of Pulmonary Arterial Hypertension|
|Study Start Date :||September 2010|
|Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||October 2011|
systemic sclerosis patients
Every patient will have a rest echocardiography, a stress echocardiography, a right heart catheterization, a blood specimen, and a pulmonary function test.
- Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization. [ Time Frame: 5 years ]Every patient will have both procedures; stress echocardiography and right heart catheterization. A positive stress echocardiography is defined as >= 20 mmhg increase in the systolic pulmonary artery pressure (SPAP) (between rest and stress) or an absolute value >= 55 mmhg. A positive right heart catheterization at rest is defined as a PAPm >25mmhg, wedge < 18 and pulmonary vascular resistances >3 wood units. Stress catheterization will also be perform and is defined as a PAPm > 30mmhg and wedge <18 mm hg.
- Correlation of a 20 mmhg increase in the PAP during stress echocardiography and elevated NT-proBNP. [ Time Frame: 5 years ]
- Function of the left ventricle (left ventricular ejection fraction) at rest and at stress. [ Time Frame: Follow up every year X 5 ]We hypothesize that patients who do not increase their left ventricular ejection fraction at stress have a worst clinical outcome in the follow up.
- Diastolic function at rest and at stress [ Time Frame: follow up every year X 5 ]We hypothesize that patients with diastolic dysfunction manifesting at stress have a worst clinical outcome in the follow up.
- Function of the right ventricle [ Time Frame: Follow up every year X 5 ]We hypothesise that in patients with or without pulmonary hypertension, right ventricular dysfunction is associated with a worse clinical outcome
Biospecimen Retention: Samples Without DNA
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): NCT01202045
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Paul Farand, md, msc||Centre de recherche du Centre hospitalier universitaire de Sherbrooke|