Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Pulmonary artery catheterization (rest and exertion) and treadmill stress echocardiography will be done to all patients of the study.

Official Title
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Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients With Indirect Signs of Pulmonary Arterial Hypertension

Conditions
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Scleroderma, Systemic, Hypertension, Pulmonary

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one of the prespecified indirect sign of pulmonary arterial hypertension Able to exercise on treadmill Exclusion Criteria: left ventricular dysfunction at rest Absence of pulmonary regurgitant flow Pregnancy or breastfeeding Smoking with > 60 pack-year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| systemic sclerosis patients<br>Every patient will have a rest echocardiography, a stress echocardiography, a right heart catheterization, a blood specimen, and a pulmonary function test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization. | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of a 20 mmhg increase in the PAP during stress echocardiography and elevated NT-proBNP. |  | 5 years | 
| Function of the left ventricle (left ventricular ejection fraction) at rest and at stress. | We hypothesize that patients who do not increase their left ventricular ejection fraction at stress have a worst clinical outcome in the follow up. | Follow up every year X 5 | 
| Diastolic function at rest and at stress | We hypothesize that patients with diastolic dysfunction manifesting at stress have a worst clinical outcome in the follow up. | follow up every year X 5 | 
| Function of the right ventricle | We hypothesise that in patients with or without pulmonary hypertension, right ventricular dysfunction is associated with a worse clinical outcome | Follow up every year X 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echocardiography, Stress, right heart catheterization