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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01202045
Other study ID # Projet # 10-111
Secondary ID
Status Withdrawn
Phase N/A
First received September 10, 2010
Last updated July 3, 2013
Start date September 2010
Est. completion date October 2011

Study information

Verified date July 2013
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Canada Centre hospitalier universitaire de Sherbrooke Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Paul Farand

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Correlation of a 20 mmhg increase in the PAP during stress echocardiography and elevated NT-proBNP. 5 years No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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