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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition
Scleroderma, Systemic
Hypertension, Pulmonary

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients With Indirect Signs of Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202045

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Paul Farand
Investigators
Principal Investigator: Paul Farand, md, msc Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Paul Farand, MD, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01202045     History of Changes
Other Study ID Numbers: Projet # 10-111
Study First Received: September 10, 2010
Last Updated: July 3, 2013
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
Echocardiography, Stress
right heart catheterization

Additional relevant MeSH terms:
Hypertension, Pulmonary
Scleroderma, Systemic
Scleroderma, Diffuse
Hypertension
Sclerosis
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014