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

Completed

• Conditions: Sjögren Syndrome; Pulmonary Hypertension

• Registration Number: NCT02752269
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
forced vital capacity	2 hours	% predicted
systolic pulmonary arterial pressure at 50 Watts	2 hours	mmHg

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria