Early Detection of Pulmonary- and Pulmonary Vascular Disease in Sjögren Syndrome

March 17, 2020 updated by: Medical University of Graz

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

86

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
    • Styria
      • Graz, Styria, Austria, 8010
        • Medical University of Graz

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 to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with primary or secondary Sjögren Syndrome.

Description

Inclusion Criteria:

  • informed Consent
  • diagnosis of Sjögren Syndrome
  • age: 18 - 90 yrs

Exclusion Criteria:

  • 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
  • larger surgical interventions within the last 12 months
  • musculoskeletal or vascular disease, that may affect ergometric investigations
  • pregnancy (anamnesis)

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
prevalence of pulmonary hypertension in Sjögren syndrome
Time Frame: 2 hours
% of patients with mean pulmonary arterial pressure > 25 mmHg
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
forced vital capacity
Time Frame: 2 hours
% predicted
2 hours
systolic pulmonary arterial pressure at 50 Watts
Time Frame: 2 hours
mmHg
2 hours

Collaborators and Investigators

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

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Horst Olschewski, MD, MUG

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

October 1, 2014

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

June 30, 2019

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

April 22, 2016

First Posted (ESTIMATE)

April 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-446 ex 13/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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