Early Detection of Pulmonary- and Pulmonary Vascular Disease in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sjögren Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Hypertension Hypertension, Pulmonary Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Lung Diseases Mouth Diseases Musculoskeletal Diseases Pulmonary Hypertension Respiratory Tract Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Vascular Diseases Xerostomia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, Styria, 8010, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

prevalence of pulmonary hypertension in Sjögren syndrome

Time frame: 2 hours

% of patients with mean pulmonary arterial pressure > 25 mmHg

Secondary outcomes

forced vital capacity

Time frame: 2 hours

% predicted
systolic pulmonary arterial pressure at 50 Watts

Time frame: 2 hours

mmHg

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Apr 26, 2016
Registry last updated: Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed