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Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension (SNOOPY2)

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ClinicalTrials.gov Identifier: NCT02782026
Recruitment Status : Unknown
Verified December 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : May 25, 2016
Last Update Posted : October 2, 2017
Sponsor:
Collaborators:
Technion, Israel Institute of Technology
Bayer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

In this prospective case-control study, the investigators will evaluate the diagnostic performance of a novel electronic nose (E-nose) for the detection of Pulmonary Arterial Hypertension (PAH). This study is designed to:

  1. Assess the performance of the E-nose to discriminate controls from patients with PAH
  2. Assess the performance of the E-nose to discriminate between different subtypes of pulmonary hypertension (PH), namely idiopathic PAH, heritable PAH with BMPR2 mutation and chronic thromboembolic PH
  3. Assess the performance of the E-nose to discriminate controls from asymptomatic patients with PH who carry BMPR2 mutations.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Device: Exhaled Breath Olfactory Signature (Artificial Nose) Not Applicable

Detailed Description:

Pulmonary arterial hypertension (PAH) is a progressive and rare severe disease (prevalence of 15-50 per million) due to obstruction of small pulmonary arteries, leading to an increase in pulmonary artery pressure with the ultimate consequence right heart failure. Despite recent advances in therapeutic care, there is no cure and most patients die or require lung transplantation within 5 years of diagnosis. Currently, right heart catheterisation is required to diagnose PAH and monitor response to treatment. Right heart catheterisation is an invasive test, and alternatives such as echocardiography have not yielded sufficient accuracy both for early diagnosis and disease monitoring. Currently, PAH is often diagnosed at an advanced stage of the disease. There is often a delay in diagnosis of several years between the first symptoms and the identification of the disease due to the non-specific nature of symptoms. Hence, there is the need to improve the time between the first signs and definitive diagnosis of the disease. Early diagnosis of PAH remains a challenge due to the low sensitivity and specificity of biomarkers available currently.

The main objective is to validate the results obtained in the previous preliminary proof of concept study - that PAH patients display a unique olfactory signature that can be detected by an artificial E- nose.

Secondary objectives are to investigate the ability of the E-nose to:

  • Discriminate patients with idiopathic PAH from those with heritable PAH due to BMPR2 mutations
  • Discriminate patients with chronic thromboembolic pulmonary hypertension (CTEPH) from healthy controls, and patients with idiopathic and/or heritable PAH.
  • Detect development of PAH in BMPR2 mutation carriers
  • Determine whether the olfactory signature can stratify subgroups of patients by correlating the olfactory signature to different biological and clinical parameters (hemodynamic measurements, NYHA class, duration of treatment, 6-minute walk distance, response to nitric oxide, BNP levels).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension Detected by an Artificial Nose: A Clinical Validation Study
Study Start Date : March 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: idiopathic PAH
Exhaled Breath Olfactory Signature Detected by an Artificial Nose
Device: Exhaled Breath Olfactory Signature (Artificial Nose)
Experimental: heritable PAH with BMPR2 mutation
Exhaled Breath Olfactory Signature Detected by an Artificial Nose
Device: Exhaled Breath Olfactory Signature (Artificial Nose)
Experimental: chronic thromboembolic PH
Exhaled Breath Olfactory Signature Detected by an Artificial Nose
Device: Exhaled Breath Olfactory Signature (Artificial Nose)
Experimental: Controls
Exhaled Breath Olfactory Signature Detected by an Artificial Nose
Device: Exhaled Breath Olfactory Signature (Artificial Nose)



Primary Outcome Measures :
  1. Volatile organic compounds in exhaled breath in patients of each group detected using sensor array on the basis of cross-reactive gold-nanoparticles coated with organic ligands. [ Time Frame: Up to 4 hours ]
    The primary endpoint will be the ability of the E-nose to discriminate patients with PAH from healthy controls by their olfactory signature from the profile of volatile organic compounds in exhaled breath.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients group

  • Age 18 to 65 years inclusive
  • Idiopathic or heritable PAH confirmed by right heart catheterization
  • Patients with CTEPH confirmed by right heart catheterization

Healthy control group:

  • Age 18 to 65 years inclusive
  • No known allergy
  • No history of known pathology
  • Not genetically linked with the patient

At risk group:

  • Subjects included in the protocol Delphi2

Exclusion Criteria:

Patients group:

Any of the following:

  • Connective tissue disease
  • Infection with HIV
  • Portal hypertension or liver disease
  • Congenital Heart Disease
  • Asthma and other coexisting lung disease

Healthy control group:

  • Pregnant or breastfeeding woman
  • Addiction to alcohol
  • Tabacco addiction

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): NCT02782026


Contacts
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Contact: Marc Humbert, MD,PhD +33 140942512 marc.humbert@bct.aphp.fr

Locations
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France
AP-HP, Bicêtre Hospital Recruiting
Le Kremlin-Bicêtre, France, 94275
Contact: Marc Humbert, MD, PhD    +33 1 45217972    marc.humbert@bct.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Technion, Israel Institute of Technology
Bayer
Investigators
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Principal Investigator: Marc Humbert, MD,PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02782026    
Other Study ID Numbers: 2014-01321-46
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
pulmonary hypertension
early detection
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases