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

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

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 Overview

• Status: Withdrawn
• Conditions: Scleroderma, Systemic; Hypertension, Pulmonary

Detailed Description

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

• Study Type: Observational

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Systemic slerosis patients with indirect signs of arterial pulmonary hypertension:

• Effort dyspnea (NYHA >= 2/4)
• DLCO < 60%
• FVC% / DLCO% > 1.6
• SPAP > 40 mmhg and < 55 mmhg

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Paul Farand
• Investigators: Principal Investigator: Paul Farand, md, msc, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: September 10, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimate): September 15, 2010

Study Record Updates

• Last Update Posted (Estimate): July 8, 2013
• Last Update Submitted That Met QC Criteria: July 3, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: right heart catheterization; Echocardiography, Stress
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Respiratory Tract Diseases; Lung Diseases; Connective Tissue Diseases; Hypertension; Scleroderma, Systemic; Scleroderma, Diffuse; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: Projet # 10-111