Systemic SclerosisNCT01468792
Hemodynamic Changes in Connective Tissue Disease
An observational study of Systemic Sclerosis, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- How many people
- 85 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2011to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with known systemic sclerosis and without known pulmonary hypertension
Who may be able to join
- 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
Who cannot join
- - 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, pulmonary arterial hypertension
- Medical subject headings
- Scleroderma, Systemic, Pulmonary Arterial Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic pulmonary pressure at 50 W
change of systolic pulmonary arterial pressure after 3-5 years
Measured: 3-5 years
Secondary outcomes (1)
peak (oxygen uptake) VO2
change of peak VO2 after 3-5 years
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horst Olschewski, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468792
- Sponsor's protocol ID
- 23-409 ex 10/11
- Other IDs
- 23-409 ex 10/11
- Status last verified
- Feb 2014
- First submitted
- 7 Nov 2011
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kovacs G, Avian A, Wutte N, Hafner F, Moazedi-Furst F, Kielhauser S, Aberer E, Brodmann M, Graninger W, Foris V, Olschewski A, Olschewski H. Changes in pulmonary exercise haemodynamics in scleroderma: a 4-year prospective study. Eur Respir J. 2017 Jul 13;50(1):1601708. doi: 10.1183/13993003.01708-2016. Print 2017 Jul.
PubMed 28705939
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes in Connective Tissue Disease
- ClinicalTrials.gov ID
- NCT01468792
- Acronym / sponsor ID
- 23-409 ex 10/11
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, pulmonary arterial hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with known systemic sclerosis and without known pulmonary hypertension
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
systolic pulmonary pressure at 50 W
Time frame: 3-5 years
change of systolic pulmonary arterial pressure after 3-5 years
1 secondary outcome
peak (oxygen uptake) VO2
Time frame: 3-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Derived from this study: PubMed 28705939Kovacs G, Avian A, Wutte N, Hafner F, Moazedi-Furst F, Kielhauser S, Aberer E, Brodmann M, Graninger W, Foris V, Olschewski A, Olschewski H. Changes in pulmonary exercise haemodynamics in scleroderma: a 4-year prospective study. Eur Respir J. 2017 Jul 13;50(1):1601708. doi: 10.1183/13993003.01708-2016. Print 2017 Jul.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Olschewski, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic pulmonary pressure at 50 W (time frame: 3-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01468792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.