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

NCT02752269 | Completed

• 1 other identifier: 26-446 ex 13/14
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjögren Syndrome; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• prevalence of pulmonary hypertension in Sjögren syndrome

  % of patients with mean pulmonary arterial pressure \> 25 mmHg

  2 hours

Secondary Outcomes (2)

• forced vital capacity

  2 hours

• systolic pulmonary arterial pressure at 50 Watts

  2 hours

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primary or secondary Sjögren Syndrome.

You may qualify if:

• informed Consent
• diagnosis of Sjögren Syndrome
• age: 18 - 90 yrs

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Horst Olschewski, MD

  MUG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: April 26, 2016
• Study Start: October 1, 2014
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)