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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
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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 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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
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


Group/Cohort
Idiopathic PAH
CTD-PAH
CTD without PAH



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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
blood exhaled air


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
See eligibility criteria
Criteria

Inclusion Criteria:

  1. 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.
  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 (2)
    • minimal age of 18 year
  3. 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

Information from the National Library of Medicine

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


Contacts
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Contact: Judith Potjewijd, MD +31 (0) 433871198 pah.uitademingslucht.int@mumc.nl

Locations
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Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Judith Potjewijd, MD    +31-(0)43-3871198    pah.uitademingslucht.int@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Pieter van Paassen, PhD Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03819777     History of Changes
Other Study ID Numbers: NL57351.068.17
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Scleroderma, Systemic
Hypertension
Familial Primary Pulmonary Hypertension
Scleroderma, Diffuse
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases