Hemodynamic Changes in Connective Tissue Disease

February 18, 2014 updated by: Medical University of Graz
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz / Pulmonology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with known systemic sclerosis and without known pulmonary hypertension

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systolic pulmonary pressure at 50 W
Time Frame: 3-5 years
change of systolic pulmonary arterial pressure after 3-5 years
3-5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peak (oxygen uptake) VO2
Time Frame: 3-5 years
change of peak VO2 after 3-5 years
3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-409 ex 10/11 (Other Grant/Funding Number: MUG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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