Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension

NCT ID: NCT02782026

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-04
• Study Completion Date: 2018-09-04

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).

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

idiopathic PAH

Exhaled Breath Olfactory Signature Detected by an Artificial Nose

Group Type: EXPERIMENTAL

Exhaled Breath Olfactory Signature (Artificial Nose)

Intervention Type: DEVICE

heritable PAH with BMPR2 mutation

Exhaled Breath Olfactory Signature Detected by an Artificial Nose

Group Type: EXPERIMENTAL

Exhaled Breath Olfactory Signature (Artificial Nose)

Intervention Type: DEVICE

chronic thromboembolic PH

Exhaled Breath Olfactory Signature Detected by an Artificial Nose

Group Type: EXPERIMENTAL

Exhaled Breath Olfactory Signature (Artificial Nose)

Intervention Type: DEVICE

Controls

Exhaled Breath Olfactory Signature Detected by an Artificial Nose

Group Type: EXPERIMENTAL

Exhaled Breath Olfactory Signature (Artificial Nose)

Intervention Type: DEVICE

Interventions

Exhaled Breath Olfactory Signature (Artificial Nose)

Intervention Type: DEVICE

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technion, Israel Institute of Technology

OTHER

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Humbert, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Countries

France

Other Identifiers

2014-01321-46

Identifier Type: -

Identifier Source: org_study_id