Volatile Organic Compounds (VOCs) as a Biomarker in Immune-mediated Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT03819777
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2018-03-01
2023-01-31
Brief Summary
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Hypothesis: first, the investigators hypothesize that at time of diagnosis the VOC profiles will discriminate patients with PAH-CTD and idiopathic PAH (IPAH) from patients with systemic sclerosis or systemic lupus erythematosus (CTD) without PAH, supporting the contention that there is a overlapping inflammatory and auto-immune pathway in PAH. During follow-up, the investigators will measure the VOC profiles of patients in all three groups who will be treated according standard clinical care. The hypothesis is that VOC profiles are affected by therapy.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Idiopathic PAH
No interventions assigned to this group
CTD-PAH
No interventions assigned to this group
CTD without PAH
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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.
* 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 (2)
* minimal age of 18 year
* 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
Exclusion Criteria
* tuberculosis or hepatitis B/C infection in case of start immunosuppressive therapy
* need to start immediately with therapy
* already use of immune suppression
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Pieter van Paassen, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Maastricht University Medical Center
Maastricht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL57351.068.17
Identifier Type: -
Identifier Source: org_study_id
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