What is the Role of the Exposome in Pulmonary Hypertension

NCT07172334 | Not Yet Recruiting

• 1 other identifier: 2025-A00986-43
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 10

Brief 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. 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)

Keywords

Pulmonary hypertension; Exposome

Outcome Measures

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

  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

  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

  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

  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

  From enrollement to the end of study at day 1

Study Arms (2)

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

Other: Questionnaires; Other: Samples

CTEPH group (controls)

Patients with chronic thromboembolic PH (CTEPH, class 4), according to the clinical classification of PH

Other: Questionnaires; Other: Samples

Interventions

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).

CTEPH group (controls); PAH group (cases)

Samples OTHER

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

CTEPH group (controls); PAH group (cases)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (10)

Bordeaux University Hospital

Bordeaux, France

Location

Brest University Hospital

Brest, France

Location

Le Kremlin Bicetre Hospital

Le Kremlin-Bicêtre, France

Location

Lille University Hospital

Lille, France

Location

Louis Pradel Hospital

Lyon, France

Location

Nancy University Hospital

Nancy, France

Location

Poitiers University Hospital

Poitiers, France

Location

Saint Etienne University Hospital

Saint-Etienne, France

Location

New Civil Hospital

Strasbourg, France

Location

Larrey Hospital

Toulouse, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Interventions

Surveys and Questionnaires; Sampling Studies

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Epidemiologic Study Characteristics

Central Study Contacts

Etienne-Marie JUTANT, MD-PhD

CONTACT

+335 49 44 33 49; etienne-marie.jutant@chu-poitiers.fr

Céline ABONNEAU, Project manager

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 15, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

FR (10)