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:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT02970851
Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic PAH (PH group 1 Dana Point / stages 2 à 4 according to NYHA classification, defined by a mean arterial pulmonary pressure \>25 millimeter of mercury (mmHg) at rest, an occlusion arterial pulmonary pressure \<15 millimeter of mercury (mmHg) and vascular pulmonary resistance \>240 dyn.s.cm-5 for which a treatment with bosentan is indicated Or Patients with CTEPH not candidate for a pulmonary endarterectomy or patient with residual CTEPH after pulmonary endarterectomy (PH group 4 Dana Point / stages 2 to 4 according to NYHA classification) and for which a treatment with bosentan is indicated
* Indication to perform a right heart catheterization in the context of PAH suspected during cardiac ultrasound
* Age from 18 to 80 years old, male and female
* Karnofsky index ≥80%
* Informed consent signed
Exclusion Criteria:
* Patients with PAH stages 2,3 or 5 of Dana Point
* Patients with a contra-indication to adenosine including severe uncontrolled asthma, severe uncontrolled chronic obstructive pulmonary disease, 2nd or 3rd degree atrioventricular block without pacemaker,
* Patients with a contraindication to Bosentan, i.e :hypersensibility to the product, hepatic failure Child Pugh B or C, aminotransferases \>3 times normal value (N),association with cyclosporine A or glibenclamide
* Pregnancy, female of child-bearing potential not using any acceptable contraceptive method, breastfeeding
* Atrial fibrillation (Ventricular Ejection Fraction (VEF) not evaluable at echography)
* Karnofsky index \<80%
* Impossibility to obtain informed consent signed
* Left cardiopathies that can be responsible of post-capillar hypertension
* Involvement in another clinical study with an unregistered drug within 30 days prior to this specific study and during the entire course of the study
* Inability to comply with study procedures (linguistic problem, psychiatric problems, dementia, confusional state)
* Known or suspected non compliance drug or alcohol abuse
* Left heart assessment : diastolic and systolic function and valvular structures to exclude a cardiac pathology
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02970851
Study Brief:
Protocol Section:
NCT02970851