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Clinical Trials/NCT01202045
NCT01202045
Withdrawn
Not Applicable

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

Paul Farand1 site in 1 countrySeptember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scleroderma, Systemic
Sponsor
Paul Farand
Locations
1
Primary Endpoint
Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization.
Status
Withdrawn
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
October 2011
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Paul Farand
Responsible Party
Sponsor Investigator
Principal Investigator

Paul Farand

MD

Université de Sherbrooke

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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)
  • Diastolic function at rest and at stress(follow up every year X 5)
  • Function of the right ventricle(Follow up every year X 5)

Study Sites (1)

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