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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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

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Sjögren Syndrome Pulmonary Hypertension

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No