Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients
The purpose of this study is to assess the value in terms of sensitivity, specificity and likelihood ratio of the stress echocardiography in the screening of pulmonary arterial hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial hypertension.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients With Indirect Signs of Pulmonary Arterial Hypertension|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Function of the left ventricle (left ventricular ejection fraction) at rest and at stress. [ Time Frame: Follow up every year X 5 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
Pulmonary artery catheterization (rest and exertion) and treadmill stress echocardiography will be done to all patients of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202045
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Paul Farand, md, msc||Centre Hospitalier Universitaire de Sherbrooke|