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Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension (SNOOPY2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782026
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : May 4, 2021
Sponsor:
Collaborators:
Technion, Israel Institute of Technology
Bayer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE February 23, 2016
First Posted Date  ICMJE May 25, 2016
Last Update Posted Date May 4, 2021
Actual Study Start Date  ICMJE March 4, 2016
Actual Primary Completion Date August 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension
Official Title  ICMJE Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension Detected by an Artificial Nose: A Clinical Validation Study
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE Device: Exhaled Breath Olfactory Signature (Artificial Nose)
Study Arms  ICMJE
  • Experimental: idiopathic PAH
    Exhaled Breath Olfactory Signature Detected by an Artificial Nose
    Intervention: Device: Exhaled Breath Olfactory Signature (Artificial Nose)
  • Experimental: heritable PAH with BMPR2 mutation
    Exhaled Breath Olfactory Signature Detected by an Artificial Nose
    Intervention: Device: Exhaled Breath Olfactory Signature (Artificial Nose)
  • Experimental: chronic thromboembolic PH
    Exhaled Breath Olfactory Signature Detected by an Artificial Nose
    Intervention: Device: Exhaled Breath Olfactory Signature (Artificial Nose)
  • Experimental: Controls
    Exhaled Breath Olfactory Signature Detected by an Artificial Nose
    Intervention: Device: Exhaled Breath Olfactory Signature (Artificial Nose)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2021)
273
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2016)
350
Actual Study Completion Date  ICMJE September 4, 2018
Actual Primary Completion Date August 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients group (Group A)

  • Age 18 to 65 years inclusive
  • Idiopathic or heritable PAH confirmed by right heart catheterization
  • Affiliated to a social security (excluding AME)

Healthy control group (Group B)

  • Age 18 to 65 years inclusive
  • No known allergy
  • No history of known pathology
  • No chronic disease in active phase
  • No history of respiratory illness
  • Not genetically linked with the patient
  • Affiliated to a social security (excluding AME)

At risk group (Group C)

  • Age between 18 and 65 years old inclusive
  • Subjects included in the protocol Delphi2 or Subject satisfying the inclusion and non-inclusion criteria of the DELPHI2 study
  • Affiliated to a social security (excluding AME)

Patient group (Group D)

  • Age between 18 and 65 years old inclusive
  • Post-embolic HTP
  • Affiliated to a social security scheme (excluding AME)

Exclusion Criteria:

Any patient/subject presenting :

  • Connective tissue disease
  • HIV infection
  • Portal hypertension
  • Congenital heart disease
  • Asthma and other coexisting lung diseases
  • Pregnant or breastfeeding woman
  • Alcohol addiction (if consumption >3 glasses/day for men and >2 glasses/day for women)
  • Smoking addiction (if consumption >5 cigarettes/day)
  • Having had a CT scan in the week prior to the inclusion visit
  • Subjects who have consumed coffee, alcohol, or a cigarette in less than 3 hours
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02782026
Other Study ID Numbers  ICMJE 2014-01321-46
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Technion, Israel Institute of Technology
  • Bayer
Investigators  ICMJE
Principal Investigator: Marc Humbert, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP