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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752269
• Other study ID #: 26-446 ex 13/14
• Status: Completed
• Start date: October 2014
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension
• Sjögren Syndrome
• Sjogren's Syndrome
• Syndrome
• Vascular Diseases

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of pulmonary hypertension in Sjögren syndrome	% of patients with mean pulmonary arterial pressure > 25 mmHg	2 hours
Secondary	forced vital capacity	% predicted	2 hours
Secondary	systolic pulmonary arterial pressure at 50 Watts	mmHg	2 hours