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
Verified date | July 2013 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Observational |
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.
Status | Withdrawn |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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Paul Farand |
Canada,
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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