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Hemodynamic Changes in Connective Tissue Disease

This study is currently recruiting participants.
Verified January 2013 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01468792
First received: November 7, 2011
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Systemic Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodynamic Changes in Connective Tissue Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • systolic pulmonary pressure at 50 W [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
    change of systolic pulmonary arterial pressure after 3-5 years


Secondary Outcome Measures:
  • peak (oxygen uptake) VO2 [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
    change of peak VO2 after 3-5 years


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

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

patients with known systemic sclerosis and without known pulmonary hypertension

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468792

Contacts
Contact: Horst Olschewski, MD +43-316-385-12183 horst.olschewski@medunigraz.at
Contact: Gabor Kovacs, MD +43-316-385-80748 gabor.kovacs@klinikum-graz.at

Locations
Austria
Medical University of Graz / Pulmonology Recruiting
Graz, Austria, 8036
Contact: Horst Olschewski, MD     +43-316-385-12183     horst.olschewski@medunigraz.at    
Contact: Gabor Kovacs, MD     +43-316-385-80748     gabor.kovacs@klinikum-graz.at    
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01468792     History of Changes
Other Study ID Numbers: 23-409 ex 10/11, 23-409 ex 10/11
Study First Received: November 7, 2011
Last Updated: January 3, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

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

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

ClinicalTrials.gov processed this record on May 23, 2013