Volatile Organic Compounds (VOCs) as a Biomarker in Immune-mediated Pulmonary Arterial Hypertension (PAH) (VOC-PAH)
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|ClinicalTrials.gov Identifier: NCT03819777|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 30, 2019
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.
|Condition or disease|
|Pulmonary Arterial Hypertension Systemic Sclerosis Systemic Lupus|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Volatile Organic Compounds as a Biomarker in Immune-mediated Pulmonary Arterial Hypertension|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||January 31, 2021|
|CTD without PAH|
- Determining unique inflammatory VOC profiles in exhaled air in three groups of patients: IPAH, PAH-CTD and CTD without PAH. [ Time Frame: 3 measurements in 2 weeks ]
Exhaled air samples will be analyzed on inflammatory VOC profiles in the diagnostic phase of the study. Three measurements over a period of two weeks will be done. Statistically analysis will report one average VOC profile of the three measurements.
Procedure: the patient is asked to exhale via a sterile mask into the ReCIVA breath sampler (Owlstone Medical, Cambridge, UK) in which mixed total exhaled air is immediately trapped and stored onto stainless-steel two-bed sorption tubes, filled with carbograph 1TD/Carbopack X (Markes International, Wales, UK). The tubes will be analyzed with GC-TOF-MS for the presence of VOCs after which multivariate statistical analysis will be used to select those VOCs unique for the various patient groups.
- Correlation between unique inflammatory VOCs to well-established biomarkers of immune activation and inflammation in PAH-CTD and idiopathic PAH. [ Time Frame: 1 measurement at baseline ]The correlation analysis by means of bivariate (Spearman correlation) and multivariate analysis (canonical correlation analysis) will be performed.
- Change (Δ, delta) from baseline in selective inflammatory VOC profiles after 3, 6 and 12 months in all patients treated with PAH and/or immunsuppressive medication. [ Time Frame: Changes (Δ, delta) between baseline, 3 months, 6 months, 9 months and 12 months ]Wilcoxon signed-rank test will be utilized to see if the individual, selective inflammatory VOCs after treatment significantly differ with the baseline measurements.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819777
|Contact: Judith Potjewijd, MD||+31 (0) email@example.com|
|Maastricht University Medical Center||Recruiting|
|Contact: Judith Potjewijd, MD +31-(0)43-3871198 firstname.lastname@example.org|
|Principal Investigator:||Pieter van Paassen, PhD||Maastricht University Medical Center|