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

Hypertension, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01202045
• Other study ID #: Projet # 10-111
• Status: Withdrawn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• Status: Withdrawn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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Scleroderma, Diffuse
• Scleroderma, Systemic

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