Sjögren SyndromeNCT02752269
Early Detection of Pulmonary- and Pulmonary Vascular Disease in Sjögren Syndrome
An observational study of Sjögren Syndrome and Pulmonary Hypertension, run by Medical University of Graz at 1 site in Austria.
Trial summary
According to the literature available pulmonary hypertension is present in 12 to 23% of patients suffering from Sjögren Syndrome. However epidemiological data are based on non-invasive measurements using echocardiography. Furthermore, no data are available regarding exercise hemodynamics in those patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sjögren Syndrome, Pulmonary Hypertension
- How many people
- 86 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2014to 30 Jun 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary or secondary Sjögren Syndrome.
Who may be able to join
- informed Consent
- diagnosis of Sjögren Syndrome
- age: 18 - 90 yrs
Who cannot join
- uncontrolled systemic hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic)
- relevant systolic (EF<50%) or diastolic (>Grade 1) left ventricular dysfunction
- uncontrolled ventricular arrhythmias
- uncontrolled supraventricular bradycardia or tachycardia
- myocardial infarction within the last 12 months
- pulmonary embolism within the last 6 months
Show all 9Show fewer
- larger surgical interventions within the last 12 months
- musculoskeletal or vascular disease, that may affect ergometric investigations
- pregnancy (anamnesis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Detection of Pulmonary- and Pulmonary Vascular Disease in Patients Suffering From Sjögren Syndrome
According to the literature available pulmonary hypertension is present in 12 to 23% of patients suffering from Sjögren Syndrome. However epidemiological data are based on non-invasive measurements using echocardiography. Furthermore, no data are available regarding exercise hemodynamics in those patients.
This study investigates pulmonary hemodynamics at rest and during exercise in patients suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary hypertension (PH) will be offered further investigations including right heart catheterization.
Read the detailed description
Patients with primary and secondary Sjögren Syndrome will be investigated using echocardiography, exercise echocardiography, pulmonary function testing, laboratory testing, electrocardiogram and 6 minute walking test. Those patients under clinical suspicion for pulmonary hypertension will be offered further investigations including right heart catheterization to rule out or verify the diagnosis of manifest pulmonary hypertension.
- Conditions
- Sjögren Syndrome, Pulmonary Hypertension
- Medical subject headings
- Sjogren's Syndrome, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of pulmonary hypertension in Sjögren syndrome
% of patients with mean pulmonary arterial pressure > 25 mmHg
Measured: 2 hours
Secondary outcomes (2)
forced vital capacity
% predicted
Measured: 2 hours
systolic pulmonary arterial pressure at 50 Watts
mmHg
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startOct 2014
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren SyndromeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 86 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, MUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752269
- Sponsor's protocol ID
- 26-446 ex 13/14
- Status last verified
- Mar 2020
- First submitted
- 24 Nov 2015
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Pulmonary- and Pulmonary Vascular Disease in Patients Suffering From Sjögren Syndrome
- ClinicalTrials.gov ID
- NCT02752269
- Acronym / sponsor ID
- 26-446 ex 13/14
- Conditions
- Sjögren Syndrome, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Apr 2016 (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.
According to the literature available pulmonary hypertension is present in 12 to 23% of patients suffering from Sjögren Syndrome. However epidemiological data are based on non-invasive measurements using echocardiography. Furthermore, no data are available regarding exercise hemodynamics in those patients.
This study investigates pulmonary hemodynamics at rest and during exercise in patients suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary hypertension (PH) will be offered further investigations including right heart catheterization.
Detailed description
Patients with primary and secondary Sjögren Syndrome will be investigated using echocardiography, exercise echocardiography, pulmonary function testing, laboratory testing, electrocardiogram and 6 minute walking test. Those patients under clinical suspicion for pulmonary hypertension will be offered further investigations including right heart catheterization to rule out or verify the diagnosis of manifest pulmonary hypertension.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary or secondary Sjögren Syndrome.
Key inclusion criteria (3 listed)
- informed Consent
- diagnosis of Sjögren Syndrome
- age: 18 - 90 yrs
Key exclusion criteria (9 listed)
- uncontrolled systemic hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic)
- relevant systolic (EF<50%) or diastolic (>Grade 1) left ventricular dysfunction
- uncontrolled ventricular arrhythmias
- uncontrolled supraventricular bradycardia or tachycardia
- myocardial infarction within the last 12 months
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
prevalence of pulmonary hypertension in Sjögren syndrome
Time frame: 2 hours
% of patients with mean pulmonary arterial pressure > 25 mmHg
2 secondary outcomes
forced vital capacity
Time frame: 2 hours
systolic pulmonary arterial pressure at 50 Watts
Time frame: 2 hours
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 18 Mar 2020.
- Individual participant dataSharing planned: No
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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
MUG
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 Sjögren Syndrome and Pulmonary Hypertension, 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 9 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 18 Mar 2020. 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?
prevalence of pulmonary hypertension in Sjögren syndrome (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2020.