Hemodynamic Changes in Connective Tissue Disease

Systemic Sclerosis Clinical Trial

Official title:

Hemodynamic Changes in Connective Tissue Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468792
• Other study ID #: 23-409 ex 10/11
• Secondary ID: 23-409 ex 10/11
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: February 18, 2014
• Start date: September 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Sclerosis

Locations

Country	Name	City	State
Austria	Medical University of Graz / Pulmonology	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic pulmonary pressure at 50 W	change of systolic pulmonary arterial pressure after 3-5 years	3-5 years	No
Secondary	peak (oxygen uptake) VO2	change of peak VO2 after 3-5 years	3-5 years	No