Hemodynamic Changes in Connective Tissue Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01468792
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : February 19, 2014
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
The study serves the identification of early forms of pulmonary arterial hypertension (PAH) in connective tissue disease and the hemodynamic follow-up of the investigated patients. The basic hypothesis is that PAH may start with a remodeling of small pulmonary arteries, which leads to a stiffening of the vessels, indicated by the inability to vasodilatation and thus a disproportional increase in pulmonary pressure during exercise. Recent studies have shown that a proportion of such patients may develop manifest PAH within a few years. The early identification of these patients and the understanding of the natural course of the disease may improve prognosis. The aim of the present study is to investigate hemodynamic and clinical changes in patients with connective tissue disease in a time interval of 3-5 years with a focus on the development of pulmonary hypertension.

Condition or disease
Systemic Sclerosis

Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodynamic Changes in Connective Tissue Disease
Study Start Date : September 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Primary Outcome Measures :
  1. systolic pulmonary pressure at 50 W [ Time Frame: 3-5 years ]
    change of systolic pulmonary arterial pressure after 3-5 years

Secondary Outcome Measures :
  1. peak (oxygen uptake) VO2 [ Time Frame: 3-5 years ]
    change of peak VO2 after 3-5 years

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with known systemic sclerosis and without known pulmonary hypertension

Inclusion Criteria:

  • Informed consent
  • Patients with systemic sclerosis, mixed connective tissue disease, (systemic lupus erythematodes) SLE or overlap syndrome
  • Existing exercise Doppler echocardiography or/and right heart catheterization 3-5 years before inclusion

Exclusion Criteria:

  • - Severe lung or bronchial disease (FEV1 <60%)
  • Systolic LV dysfunction (LVEF <50%) or diastolic dysfunction > grade I
  • Valvular defect > grade I (except for tricuspid- or pulmonary insufficiency)
  • Uncontrolled systemic arterial hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic)
  • Uncontrolled ventricular arrhythmias
  • Uncontrolled bradycardia or tachycardia supraventricular arrhythmias
  • Myocardial infarction within the last 12 months
  • Pulmonary embolism within the last 12 months
  • Relevant changes in hemodynamic therapy or major surgery within the last 12 weeks
  • Musculoskeletal or peripheral vessel disorders which complicates an ergometry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01468792

Medical University of Graz / Pulmonology
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Horst Olschewski, MD Medical University of Graz

Responsible Party: Medical University of Graz Identifier: NCT01468792     History of Changes
Other Study ID Numbers: 23-409 ex 10/11
23-409 ex 10/11 ( Other Grant/Funding Number: MUG )
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Medical University of Graz:
systemic sclerosis
pulmonary arterial hypertension

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Pathologic Processes
Skin Diseases