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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Paul Farand, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01202045
First received: September 10, 2010
Last updated: July 3, 2013
Last verified: July 2013

September 10, 2010
July 3, 2013
September 2010
October 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01202045 on ClinicalTrials.gov Archive Site
  • Correlation of a 20 mmhg increase in the PAP during stress echocardiography and elevated NT-proBNP. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Function of the left ventricle (left ventricular ejection fraction) at rest and at stress. [ Time Frame: Follow up every year X 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: follow up every year X 5 ] [ Designated as safety issue: No ]
    We hypothesize that patients with diastolic dysfunction manifesting at stress have a worst clinical outcome in the follow up.
  • Function of the right ventricle [ Time Frame: Follow up every year X 5 ] [ Designated as safety issue: No ]
    We hypothesise that in patients with or without pulmonary hypertension, right ventricular dysfunction is associated with a worse clinical outcome
Same as current
Not Provided
Not Provided
 
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

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood

Non-Probability Sample

Systemic slerosis patients with indirect signs of arterial pulmonary hypertension:

  • Effort dyspnea (NYHA >= 2/4)
  • DLCO < 60%
  • FVC% / DLCO% > 1.6
  • SPAP > 40 mmhg and < 55 mmhg
  • Scleroderma, Systemic
  • Hypertension, Pulmonary
Not Provided
systemic sclerosis patients
Every patient will have a rest echocardiography, a stress echocardiography, a right heart catheterization, a blood specimen, and a pulmonary function test.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01202045
Projet # 10-111
No
Paul Farand, Universitaire de Sherbrooke
Paul Farand
Not Provided
Principal Investigator: Paul Farand, md, msc Centre Hospitalier Universitaire de Sherbrooke
Université de Sherbrooke
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP