NL-OMON52988CompletedNot Applicable
Volatile organic compounds as a biomarker in immune-mediated pulmonary arterial hypertension - Volatile organic compounds and pulmonary arterial hypertension
Medisch Universitair Ziekenhuis Maastricht0 sites150 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1) PAH-CTD patients, inclusion criteria:
- •- classification as definite systemic sclerosis or systemic lupus erythematosus
- •according to respectively the ACR-EULAR criteria and SLICC criteria
- •- minimal age of 18 year
- •- diagnosis of pulmonary arterial hypertension: mean pulmonary artery pressure
- •(mPAP) of >=25 mmHg, pulmonary capillary wedge pressure (PCWP) <=15 mmHg, and a
- •pulmonary vascular resistance (PVR) >=240 dynes.s.cm-5 measured by right heart
- •catherization. , 2) IPAH patients, inclusion criteria:
- •- diagnosis of pulmonary arterial hypertension: mean pulmonary artery pressure
- •(mPAP) of >=25 mmHg, pulmonary capillary wedge pressure (PCWP) <=15 mmHg, and a
- •pulmonary vascular resistance (PVR) >=240 dynes.s.cm-5 measured by right heart
- •catherization.
- •- no family history of PAH
- •- triggering factor is excluded: connective tissue disease, drugs or toxins,
- •human immunodeficiency virus, congenital heart disease, portal hypertension,
- •schistosomiasis
- •- minimal age of 18 year, 3) SSc and SLE patients without PAH, inclusion
- •- classification as definite systemic sclerosis or systemic lupus erythematosus
- •according to respectively the ACR-EULAR criteria (16) and SLICC criteria (17)
- •- minimal age of 18 year
- •- no signs of PAH at screening visit
- •4) CTEPH patients, inclusion criteria:
- •- diagnosis of pulmonary hypertension: mean pulmonary artery pressure
- •(mPAP) of >=25 mmHg, pulmonary capillary wedge pressure (PCWP) <=15 mmHg measured
- •by right heart catherization.
- •- mismatched perfusion defects on V/Q lung scan
Exclusion Criteria
- •- active or treated malignancy
- •- tuberculosis or hepatitis B/C infection in case of immunosuppressive
- •- need to start immediately with immunosuppressive therapy
- •- already use of immune suppression
Investigators
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