Hemodynamic Changes in Connective Tissue Disease

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz / Pulmonology

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

systolic pulmonary pressure at 50 W

Time frame: 3-5 years

change of systolic pulmonary arterial pressure after 3-5 years

Secondary outcomes

peak (oxygen uptake) VO2

Time frame: 3-5 years

change of peak VO2 after 3-5 years

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Nov 9, 2011
Registry last updated: Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed