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

Withdrawn

• Conditions: Scleroderma, Systemic; Hypertension, Pulmonary

• Registration Number: NCT01202045
• Lead Sponsor: Paul Farand

Brief Summary

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

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-03
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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	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	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

Trial Locations

Locations (1)

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada