Status:
COMPLETED
Hemodynamic Changes in Connective Tissue Disease
Lead Sponsor:
Medical University of Graz
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18+ years
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 hypothesi...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01468792
Start Date
September 1 2011
End Date
February 1 2014
Last Update
February 19 2014
Active Locations (1)
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1
Medical University of Graz / Pulmonology
Graz, Austria, 8036