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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02909608
Eligibility Criteria:
Inclusion Criteria for children with PAH:
1. Ages 8-14 years at the time of consent
2. Current diagnosis of pulmonary hypertension in WHO Diagnostic Group 1 as per established clinical criteria
Inclusion Criteria for Control children:
1. Ages 8-14 years at the time of consent
2. Absence of significant cardiopulmonary disease as per medical history
Exclusion criteria for children with PAH:
1. Current disease severity of Panama functional class IIIb or IV
2. Any bone, neuromuscular, or other pathology that may limit activity
3. Use of any medications known to limit activity
4. Active infection, or has any of the following:
* cardiovascular,
* liver,
* renal,
* hematologic,
* gastrointestinal,
* immunologic,
* endocrine,
* metabolic, or
* central nervous system
disease or condition that, in the opinion of the Investigator, may adversely affect the safety of the subject or interfere with the interpretation of study assessments.
5. Actively listed for transplantation
6. Subject and/or legal guardian has/have
* an unstable psychiatric condition or
* is/are mentally incapable of understanding the objectives, nature, or consequences of the trial, or
* has any condition in which the Investigator's opinion would constitute an unacceptable risk to the subject's safety.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
14 Years
Study:
NCT02909608
Study Brief:
Protocol Section:
NCT02909608