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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT02845518
Eligibility Criteria:
Inclusion Criteria:
* 18-75 years of age,
* Incident cases of PAH, or Prevalent cases of PAH diagnosed for less than 12 months when a re-evaluation is indicated including a right heart catheterization with the intention of modifying the specific-PAH treatment: from mono to dual therapy or from bi to triple therapy (if the 3rd treatment planned is parenteral epoprostenol, the centre must be able to perform an MRI under epoprostenol IV),
* Idiopathic, heritable PAH, or PAH associated with medication or toxic, or systemic scleroderma, or HIV infection or portal hypertension, or PAH associated with repaired (\> 1 year) congenital systemic-to-pulmonary shunt.
Patients included in a biomedical trial to test a pharmaceutical treatment will be eligible provided that there is no incompatibility between the 2 studies.
Exclusion Criteria:
* Contraindication of cardiac MRI and impossibility to undergo MRI,
* Patients not in normal sinus rhythm at baseline,
* Patients with PH (pulmonary hypertension) due to left heart disease,
* Patients with PH due to lung diseases and/or hypoxemia,
* Chronic thromboembolic pulmonary hypertension,
* Comorbidities with a significant impact on the cardiovascular system such as valvulopathies, cardiomyopathy, severe hypertension despite appropriate treatment,
* Pregnancy,
* Patients under a measure of legal protection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02845518
Study Brief:
Protocol Section:
NCT02845518