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

N/AWithdrawnNCT01202045

Paul Farand

Overview

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.

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

Study Type

OBSERVATIONAL

Conditions

Scleroderma, Systemic Hypertension, Pulmonary

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

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.

We hypothesize that patients who do not increase their left ventricular ejection fraction at stress have a worst clinical outcome in the follow up.

Time frame: 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.

Time frame: 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

Time frame: Follow up every year X 5

Data from ClinicalTrials.gov

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