Status:
UNKNOWN
Volatile Organic Compounds (VOCs) as a Biomarker in Immune-mediated Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Pulmonary Arterial Hypertension
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
Aim: to investigate the role of inflammation and auto-immunity in pulmonary arterial hypertension by using the profile of volatile organic compounds. Hypothesis: first, the investigators hypothesize ...
Eligibility Criteria
Inclusion
- PAH-CTD patients, inclusion criteria:
- 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
- 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.
- 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 (2)
- minimal age of 18 year
- SSc and SLE (CTD) patients without PAH, inclusion criteria:
- 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
- active or treated malignancy
- tuberculosis or hepatitis B/C infection in case of start immunosuppressive therapy
- need to start immediately with therapy
- already use of immune suppression
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03819777
Start Date
March 1 2018
End Date
January 31 2023
Last Update
September 8 2021
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Netherlands