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

M

Medical University of Graz

Status

Completed

Conditions

Sjögren Syndrome
Pulmonary Hypertension

Study type

Observational

Funder types

Other

Identifiers

NCT02752269
26-446 ex 13/14

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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