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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04282434
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed patients with World Health Organization (WHO) Group I PAH.
* ≥ 18 years
* Documentation of the following hemodynamic parameters by right heart catheterization, performed at time of study enrolment:
* Mean pulmonary arterial pressure (mPAP) \> 25 mmHg at rest or mPAP \> 30 mm Hg with exercise.
* Pulmonary arterial wedge pressure (PAWP) ≤ 15 mm Hg.
* Pulmonary vascular resistance (PVR) ≥ 240 dynes.sec.cm-5 (e.g., ≥ 3.0 Wood units)
Exclusion Criteria:
* Patients who meet the criteria for inclusion into WHO Groups II, III, IV or V.
* Do not meet the required hemodynamic criteria for entry into the study.
* Patients with known history of cancer, malignancy disorders, active infections, and chronic or immune-mediated diseases.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04282434
Study Brief:
Protocol Section:
NCT04282434