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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01202045

Enrollment

Registered

2010-09-15

Start date

2010-09-30

Completion date

2011-10-31

Last updated

2013-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary, Scleroderma, Systemic

Keywords

Echocardiography, Stress, right heart catheterization

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Canada

Outcome results