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

Sponsor
Medical University of Graz (Other)
Overall Status
Completed
CT.gov ID
NCT02752269
Collaborator
(none)
86
Enrollment
1
Location
56.9
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    86 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Early Detection of Pulmonary- and Pulmonary Vascular Disease in Patients Suffering From Sjögren Syndrome
    Study Start Date :
    Oct 1, 2014
    Actual Primary Completion Date :
    Jun 30, 2019
    Actual Study Completion Date :
    Jun 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. prevalence of pulmonary hypertension in Sjögren syndrome [2 hours]

      % of patients with mean pulmonary arterial pressure > 25 mmHg

    Secondary Outcome Measures

    1. forced vital capacity [2 hours]

      % predicted

    2. systolic pulmonary arterial pressure at 50 Watts [2 hours]

      mmHg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Graz Graz Styria Austria 8010

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    • Principal Investigator: Horst Olschewski, MD, MUG

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT02752269
    Other Study ID Numbers:
    • 26-446 ex 13/14
    First Posted:
    Apr 26, 2016
    Last Update Posted:
    Mar 18, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Hypertension, Pulmonary
    Vascular Diseases
    Syndrome

    Study Results

    No Results Posted as of Mar 18, 2020