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NCT Number: NCT07172334

What is the Role of the Exposome in Pulmonary Hypertension

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.

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Key information

Conditions

Pulmonary Arterial Hypertension (PAH) Cardiovascular Diseases Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bordeaux University Hospital, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

questionnaires

Other

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).

Samples

Other

Two strands of hair (or beard or axillary hair) will be taken, along with a urine and blood sample.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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.

  2. 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

    Compare the results of work schedules based on standardized questionnaires. Compare the results of job-exposure matrices applied to work schedules.

  3. 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

    Compare the medication history corresponding to a 2-year exposure assessment for each drug studied.

  4. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Céline ABONNEAU, Project manager

CONTACT

Etienne-Marie JUTANT, MD-PhD

CONTACT

[email protected]

+335 49 44 33 49

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: EXPOSPAH

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Sep 15, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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