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

Early Detection of Pulmonary- and Pulmonary Vascular Disease in Patients Suffering From Sjögren Syndrome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02752269

Enrollment

Registered

2016-04-26

Start date

2014-10-31

Completion date

2019-06-30

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension, Sjögren Syndrome

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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
prevalence of pulmonary hypertension in Sjögren syndrome	2 hours	% of patients with mean pulmonary arterial pressure \> 25 mmHg

Secondary

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

Countries

Austria

Outcome results