Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-07 @ 7:22 PM
Study NCT ID:
NCT07172334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What is the Role of the Exposome in Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D012494', 'term': 'Sampling Studies'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Two strands of hair (or beard or axillary hair) will be taken, along with a urine and blood sample.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the concentration of 180 environmental toxins of interest in the hair and urine of patients with newly diagnosed PAH and CTEPH, diagnosed in one of the reference or competence centers of the French PAH network.', 'timeFrame': 'From enrollement to the end of study at day 1'}], 'secondaryOutcomes': [{'measure': 'Compare broad screening of hair and urine for environmental toxicants and drugs in PAH and CTEPH patients', 'timeFrame': 'From enrollement to the end of study at day 1'}, {'measure': 'Compare each of the 4 exposure domains (toxic agents (drugs and medications), occupational exposures, environmental exposures and socioeconomic factors) individually between PAH and CTEPH patients.', 'timeFrame': 'From enrollement to the end of study at day 1'}, {'measure': 'Compare the exposome of PAH patients and CTEPH patients, divided into 4 domains including toxic agents using a combination of direct measurements on hair and urine and indirect measurements via questionnaires.', 'timeFrame': 'From enrollement to the end of study at day 1', 'description': 'Compare the exposome of PAH patients and CTEPH patients, divided into 4 domains including toxic agents (drugs and medications), occupational and environmental exposures and socioeconomic factors, using a combination of direct measurements on hair and urine and indirect measurements via questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary hypertension', 'Exposome'], 'conditions': ['Pulmonary Arterial Hypertension (PAH)', 'Chronic Thromboembolic Pulmonary Hypertension (CTEPH)']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major patients understanding French language with pre-capillary PH confirmed by cardiac catheterization during the year (PAH without associated pathology and CTEPH class 4)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consent signed by the participant\n* Age ≥ 18 years\n* Free subject, under no legal protection\n* Good understanding of the French language, allowing to answer the questionnaires\n* Incident 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) :\n\n * Cases: Patients with PAH without associated pathology: idiopathic or heritable, or with features of venous/capillary involvement, according to the clinical classification of PH\n * Controls: Patients with chronic thromboembolic PH (CTE-PTH, class 4), according to the clinical classification of PH.\n\nExclusion Criteria:\n\n* Patients classified as HTP groups 2, 3 or 5\n* 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)\n* 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)\n* Patients refusing hair sampling or having no hair \\> 2 cm to allow sampling\n* 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'}, 'identificationModule': {'nctId': 'NCT07172334', 'acronym': 'EXPOSPAH', 'briefTitle': 'What is the Role of the Exposome in Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'What is the Role of the Exposome in Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '2025-A00986-43'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PAH group (cases)', 'description': 'Patients with PAH without associated pathology: idiopathic or heritable, or with features of venous/capillary involvement, according to the clinical classification of PH', 'interventionNames': ['Other: Questionnaires', 'Other: Samples']}, {'label': 'CTEPH group (controls)', 'description': 'Patients with chronic thromboembolic PH (CTEPH, class 4), according to the clinical classification of PH', 'interventionNames': ['Other: Questionnaires', 'Other: Samples']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['CTEPH group (controls)', 'PAH group (cases)']}, {'name': 'Samples', 'type': 'OTHER', 'description': 'Two strands of hair (or beard or axillary hair) will be taken, along with a urine and blood sample.', 'armGroupLabels': ['CTEPH group (controls)', 'PAH group (cases)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Etienne-Marie JUTANT, MD-PhD', 'role': 'CONTACT', 'email': 'etienne-marie.jutant@chu-poitiers.fr', 'phone': '+335 49 44 33 49'}], 'overallOfficials': [{'name': 'Céline ABONNEAU, Project Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Poitiers University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}