Volatile Organic Compounds (VOCs) as a Biomarker in Immune-mediated Pulmonary Arterial Hypertension (PAH)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    150
  • sponsor
    Maastricht University Medical Center
Updated on 15 September 2021
hypertension
heart disease
connective tissue disease
rheumatism
lupus
progressive systemic sclerosis

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 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.

Details
Condition CONNECTIVE TISSUE DISEASE, Scleroderma, Systemic sclerosis, Dermatosis, Dermatomyositis (Connective Tissue Disease), Pulmonary Arterial Hypertension, Congenital Skin Diseases, Systemic Lupus, Skin Conditions, Connective Tissue Diseases, progressive systemic sclerosis
Clinical Study IdentifierNCT03819777
SponsorMaastricht University Medical Center
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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