Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT07172334
Eligibility Criteria:
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
* 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) :
* 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 (CTE-PTH, 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07172334
Study Brief:
Protocol Section:
NCT07172334