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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02610660
Eligibility Criteria:
Inclusion Criteria:
* Patient must be an incident patient, i.e.newly diagnosed with PH
* Age at time of diagnosis is at least 3 months and less than 18 years
* Patients must present with PH belonging to one of the following categories
* Group 1 according to updated Nice clinical classification
* Group 3 according to updated Nice clinical classification
* Group 4 according to updated Nice clinical classification
* Group 5 according to updated Nice clinical classification
* PH confirmed by heart catheterisation (HC)
* At HC, the patient must present with mean pulmonary arterial pressure (PAP) of at least 25 mmHg at rest, a pulmonary vascular resistance index (PVRi) equal to or below 3 Wood units\*m\^2 and mean pulmonary arterial wedge pressure (PAWP) below or equal to 15 mmHg
* In case of congenital heart disease (CHD) patients who had undergone palliative procedure or repair to close systemic to pulmonary shunt, the diagnosis of PH must have been confirmed by HC at least 6 months after surgery/palliative procedure took place
* For patients with PAH-CHD open shunt, only those considered not operable due to advanced pulmonary vascular disease are eligible
* Patients to be included into the registry, and/or their legal guardians, must give informed consent. Where applicable patients will be asked for their written assent
* Participating sites must agree to adhere to the recommendations of the WSPH 2015 Nice, Pediatric Taskforce.
Exclusion Criteria:
* Patients belonging to Group 2 according to updated Nice clinical classification
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
18 Years
Study:
NCT02610660
Study Brief:
Protocol Section:
NCT02610660