Pulmonary HypertensionSNOOPY2NCT02782026
Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension
A study testing Exhaled Breath Olfactory Signature (Artificial Nose) in people with Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Exhaled Breath Olfactory Signature (Artificial Nose)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2016to 4 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- Any patient/subject presenting :
- Connective tissue disease
- HIV infection
- Portal hypertension
- Congenital heart disease
- Asthma and other coexisting lung diseases
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension Detected by an Artificial Nose: A Clinical Validation Study
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:
- Assess the performance of the E-nose to discriminate controls from patients with PAH
- 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
- Assess the performance of the E-nose to discriminate controls from asymptomatic patients with PH who carry BMPR2 mutations.
Read the 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).
- Conditions
- Pulmonary Hypertension
- Being tested
- Exhaled Breath Olfactory Signature (Artificial Nose)
- Keywords
- pulmonary hypertension, early detection
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled Breath Olfactory Signature (Artificial Nose)Device
| Study group | Role | What they receive |
|---|---|---|
| idiopathic PAH | Experimental | Exhaled Breath Olfactory Signature Detected by an Artificial Nose Receives: Device: Exhaled Breath Olfactory Signature (Artificial Nose) |
| heritable PAH with BMPR2 mutation | Experimental | Exhaled Breath Olfactory Signature Detected by an Artificial Nose Receives: Device: Exhaled Breath Olfactory Signature (Artificial Nose) |
| chronic thromboembolic PH | Experimental | Exhaled Breath Olfactory Signature Detected by an Artificial Nose Receives: Device: Exhaled Breath Olfactory Signature (Artificial Nose) |
| Controls | Experimental | Exhaled Breath Olfactory Signature Detected by an Artificial Nose Receives: Device: Exhaled Breath Olfactory Signature (Artificial Nose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start4 Mar 2016
- Primary completion28 Aug 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology, Bayer
- Responsible party
- Sponsor
- Investigators
- Marc Humbert, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782026
- Sponsor's protocol ID
- 2014-01321-46
- Other IDs
- 2014
- Acronym
- SNOOPY2
- Status last verified
- Dec 2016
- First submitted
- 23 Feb 2016
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension Detected by an Artificial Nose: A Clinical Validation Study
- ClinicalTrials.gov ID
- NCT02782026
- Acronym / sponsor ID
- SNOOPY2 / 2014-01321-46
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, early detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology, Bayer
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the performance of the E-nose to discriminate controls from patients with PAH
- 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
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| idiopathic PAH | Experimental | Device: Exhaled Breath Olfactory Signature (Artificial Nose)Exhaled Breath Olfactory Signature Detected by an Artificial Nose |
| heritable PAH with BMPR2 mutation | Experimental | Device: Exhaled Breath Olfactory Signature (Artificial Nose)Exhaled Breath Olfactory Signature Detected by an Artificial Nose |
| chronic thromboembolic PH | Experimental | Device: Exhaled Breath Olfactory Signature (Artificial Nose)Exhaled Breath Olfactory Signature Detected by an Artificial Nose |
| Controls | Experimental | Device: Exhaled Breath Olfactory Signature (Artificial Nose)Exhaled Breath Olfactory Signature Detected by an Artificial Nose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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)
Key exclusion criteria (11 listed)
- Connective tissue disease
- HIV infection
- Portal hypertension
- Congenital heart disease
- Asthma and other coexisting lung diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exhaled Breath Olfactory Signature (Artificial Nose) | Device | Controls, chronic thromboembolic PH, heritable PAH with BMPR2 mutation, idiopathic PAH |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Humbert, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exhaled Breath Olfactory Signature (Artificial Nose) in people with Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.