NCT02782026

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. 1.Assess the performance of the E-nose to discriminate controls from patients with PAH
  2. 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. 3.Assess the performance of the E-nose to discriminate controls from asymptomatic patients with PH who carry BMPR2 mutations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

March 4, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2018

Completed
Last Updated

May 4, 2021

Status Verified

December 1, 2016

Enrollment Period

2.5 years

First QC Date

February 23, 2016

Last Update Submit

April 30, 2021

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertensionearly detection

Outcome Measures

Primary Outcomes (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.

    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.

    Up to 4 hours

Study Arms (4)

idiopathic PAH

EXPERIMENTAL

Exhaled Breath Olfactory Signature Detected by an Artificial Nose

Device: Exhaled Breath Olfactory Signature (Artificial Nose)

heritable PAH with BMPR2 mutation

EXPERIMENTAL

Exhaled Breath Olfactory Signature Detected by an Artificial Nose

Device: Exhaled Breath Olfactory Signature (Artificial Nose)

chronic thromboembolic PH

EXPERIMENTAL

Exhaled Breath Olfactory Signature Detected by an Artificial Nose

Device: Exhaled Breath Olfactory Signature (Artificial Nose)

Controls

EXPERIMENTAL

Exhaled Breath Olfactory Signature Detected by an Artificial Nose

Device: Exhaled Breath Olfactory Signature (Artificial Nose)

Interventions

Exhaled Breath Olfactory Signature (Artificial Nose)DEVICE
Controlschronic thromboembolic PHheritable PAH with BMPR2 mutationidiopathic PAH

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +4 more criteria

You may not qualify if:

  • 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)
  • Subjects who have consumed coffee, alcohol, or a cigarette in less than 3 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Electronic Nose

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesElectrical Equipment and Supplies

Study Officials

  • Marc Humbert, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

May 25, 2016

Study Start

March 4, 2016

Primary Completion

August 28, 2018

Study Completion

September 4, 2018

Last Updated

May 4, 2021

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)