Pulmonary Arterial Hypertension (PAH)EXPOSPAHNCT07172334
What is the Role of the Exposome in Pulmonary Hypertension
An observational study of Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH), run by Poitiers University Hospital at 10 sites in France.
Trial summary
Pulmonary arterial hypertension (PAH) is a rare and incurable disease affecting people of all ages. It is characterized by obstructive remodeling of the small pulmonary arteries, responsible for an increase in pulmonary arterial pressure, leading to right heart failure and death in the absence of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- What is being tested?
- Questionnaires and Samples
- How many people
- 150 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2027to Jan 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patients understanding French language with pre-capillary PH confirmed by cardiac catheterization during the year (PAH without associated pathology and CTEPH class 4)
Who may be able to join
- Consent signed by the participant
- Age ≥ 18 years
- Free subject, under no legal protection
- Good understanding of the French language, allowing to answer the questionnaires
- Patients with pre-capillary PH confirmed by cardiac catheterization (PAPm > 20mmHg, PCP ≤ 15 mmHg, RVP > 2UW) having had the right diagnostic cardiac catheterization within one year (≤1 year) :
- Cases: Patients with PAH without associated pathology: idiopathic or heritable, or with features of venous/capillary involvement, according to the clinical classification of PH
- Controls: Patients with chronic thromboembolic PH (CTEPH, class 4), according to the clinical classification of PH.
Who cannot join
- Patients classified as HTP groups 2, 3 or 5
- Patients with a diagnosis of PAH associated with a connective tissue disease, HIV, portal hypertension, congenital heart disease, bilharzia, or a drug or toxic cause considered certain according to the international classification (Aminorex, Benfluorex, Carfilzomib, Dasatinib, Dexfenfluramine, Fenfluramine, Methamphetamines, Mitomycin C, adulterated rapeseed oil)
- Patients with signs of right heart failure requiring amines and/or intensive care hospitalization at time of visit (may be included at a later visit)
- Patients refusing hair sampling or having no hair > 2 cm to allow sampling
- Patients benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection, and patients in emergency situations
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Céline ABONNEAU, Project manager contact
10 sites in 1 country
France10 sites
Bordeaux University Hospital
Bordeaux
Brest University Hospital
Brest
Le Kremlin Bicetre Hospital
Le Kremlin-Bicêtre
Lille University Hospital
Lille
Louis Pradel Hospital
Lyon
Nancy University Hospital
Nancy
Poitiers University Hospital
Poitiers
Saint Etienne University Hospital
Saint-Etienne
New Civil Hospital
Strasbourg
Larrey Hospital
Toulouse
About this study
Pulmonary arterial hypertension (PAH) is a rare and incurable disease affecting people of all ages. It is characterized by obstructive remodeling of the small pulmonary arteries, responsible for an increase in pulmonary arterial pressure, leading to right heart failure and death in the absence of treatment. PAH can be associated with a variety of diseases, but around half of all PAH cases are idiopathic or hereditary, and may develop on predisposed terrain following a "second hit", as suggested by the identification of PAH cases associated with the use of anorectic drugs, methamphetamine and occupational exposure to organic solvents. No study has systematically analyzed the exposome of patients with PAH, combining environmental and occupational exposures as well as drugs and medications.
The exposome of patients with PAH without associated causes will be compared with that of patients with another form of pulmonary hypertension (PH), linked to thromboembolic risk factors: chronic thromboembolic PH (CTEPH), which will constitute the control group.
- Conditions
- Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Being tested
- Questionnaires, Samples
- Keywords
- Pulmonary hypertension, Exposome
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Patients will complete questionnaires on professional exposures with the help of a trained professional (estimated time: 30 minutes), followed by self-questionnaires on indoor and outdoor pollution, medications, drugs and socio-economic variables (estimated time: 30 minutes).
SamplesOther
Two strands of hair (or beard or axillary hair) will be taken, along with a urine and blood sample.
| Study group | Role | What they receive |
|---|---|---|
| PAH group (cases) | Patients with PAH without associated pathology: idiopathic or heritable, or with features of venous/capillary involvement, according to the clinical classification of PH Receives: Other: Questionnaires; Other: Samples | |
| CTEPH group (controls) | Patients with chronic thromboembolic PH (CTEPH, class 4), according to the clinical classification of PH Receives: Other: Questionnaires; Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the exposome assessed based on the concentration of 190 environmental toxins, drugs and medications of interest in the hair and urine of patients newly diagnosed with PAH or CTEPH
Measured: From enrollement to the end of study at day 1
Secondary outcomes (4)
To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of outdoor and indoor environmental exposures
Compare indoor and outdoor exposure questionnaires as well as the EPICES socioeconomic assessment questionnaire.
Compare environmental exposures using a composite score of indoor and outdoor pollution.
Compare concentrations of NO₂, PM10, and PM2.5 to pollutants assessed based on patients' addresses.
Compare broad-based screening of hair and urine for the presence of environmental toxins.
Measured: From enrollement to the end of study at day 1
To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of occupational exposures
Compare the results of work schedules based on standardized questionnaires. Compare the results of job-exposure matrices applied to work schedules.
Measured: From enrollement to the end of study at day 1
To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of medications exposures
Compare the medication history corresponding to a 2-year exposure assessment for each drug studied.
Measured: From enrollement to the end of study at day 1
To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of drug exposures
Compare substance use questionnaires. Compare questionnaires on substance use disorders. Compare questionnaires on associated risky behaviors. Compare broad-range drug screening of hair and urine.
Measured: From enrollement to the end of study at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172334
- Sponsor's protocol ID
- 2025-A00986-43
- Acronym
- EXPOSPAH
- Status last verified
- Jul 2026
- First submitted
- 3 Sep 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Role of the Exposome in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07172334
- Acronym / sponsor ID
- EXPOSPAH / 2025-A00986-43
- Conditions
- Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Keywords
- Pulmonary hypertension, Exposome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 15 Sep 2025 (actual)
- 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.
Pulmonary arterial hypertension (PAH) is a rare and incurable disease affecting people of all ages. It is characterized by obstructive remodeling of the small pulmonary arteries, responsible for an increase in pulmonary arterial pressure, leading to right heart failure and death in the absence of treatment. PAH can be associated with a variety of diseases, but around half of all PAH cases are idiopathic or hereditary, and may develop on predisposed terrain following a "second hit", as suggested by the identification of PAH cases associated with the use of anorectic drugs, methamphetamine and occupational exposure to organic solvents. No study has systematically analyzed the exposome of patients with PAH, combining environmental and occupational exposures as well as drugs and medications.
The exposome of patients with PAH without associated causes will be compared with that of patients with another form of pulmonary hypertension (PH), linked to thromboembolic risk factors: chronic thromboembolic PH (CTEPH), which will constitute the control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAH group (cases) | – | Other: Questionnaires, Other: SamplesPatients with PAH without associated pathology: idiopathic or heritable, or with features of venous/capillary involvement, according to the clinical classification of PH |
| CTEPH group (controls) | – | Other: Questionnaires, Other: SamplesPatients with chronic thromboembolic PH (CTEPH, class 4), according to the clinical classification of PH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients understanding French language with pre-capillary PH confirmed by cardiac catheterization during the year (PAH without associated pathology and CTEPH class 4)
Key inclusion criteria (7 listed)
- Consent signed by the participant
- Age ≥ 18 years
- Free subject, under no legal protection
- Good understanding of the French language, allowing to answer the questionnaires
- Patients with pre-capillary PH confirmed by cardiac catheterization (PAPm > 20mmHg, PCP ≤ 15 mmHg, RVP > 2UW) having had the right diagnostic cardiac catheterization within one year (≤1 year) :
Key exclusion criteria (5 listed)
- Patients classified as HTP groups 2, 3 or 5
- Patients with a diagnosis of PAH associated with a connective tissue disease, HIV, portal hypertension, congenital heart disease, bilharzia, or a drug or toxic cause considered certain according to the international classification (Aminorex, Benfluorex, Carfilzomib, Dasatinib, Dexfenfluramine, Fenfluramine, Methamphetamines, Mitomycin C, adulterated rapeseed oil)
- Patients with signs of right heart failure requiring amines and/or intensive care hospitalization at time of visit (may be included at a later visit)
- Patients refusing hair sampling or having no hair > 2 cm to allow sampling
- Patients benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection, and patients in emergency situations
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 |
|---|---|---|
| QuestionnairesPatients will complete questionnaires on professional exposures with the help of a trained professional (estimated time: 30 minutes), followed by self-questionnaires on indoor and outdoor pollution, medications, drugs and socio-economic variables (estimated time: 30 minutes). | Other | CTEPH group (controls), PAH group (cases) |
| SamplesTwo strands of hair (or beard or axillary hair) will be taken, along with a urine and blood sample. | Other | CTEPH group (controls), PAH group (cases) |
Primary outcome
To compare the exposome assessed based on the concentration of 190 environmental toxins, drugs and medications of interest in the hair and urine of patients newly diagnosed with PAH or CTEPH
Time frame: From enrollement to the end of study at day 1
4 secondary outcomes
To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of outdoor and indoor environmental exposures
Time frame: From enrollement to the end of study at day 1
To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of occupational exposures
Time frame: From enrollement to the end of study at day 1
To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of medications exposures
Time frame: From enrollement to the end of study at day 1
To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of drug exposures
Time frame: From enrollement to the end of study at day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Céline ABONNEAU, Project manager contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH), run by Poitiers University Hospital at 10 sites 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Etienne-Marie JUTANT, MD-PhD (+335 49 44 33 49, etienne-marie.jutant@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the exposome assessed based on the concentration of 190 environmental toxins, drugs and medications of interest in the hair and urine of patients newly diagnosed with PAH or CTEPH (time frame: From enrollement to the end of study at day 1). 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 22 Jul 2026.