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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT04451850
Eligibility Criteria:
Inclusion Criteria:
* All adult patients (ages 18-70) of any functional class with a new diagnosis of PAH (World health Organization Group 1) placed on targeted therapy
* Eligible PAH etiologies include idiopathic PAH, associated with connective tissue disease, human immunodeficiency virus, hereditary, or portopulmonary hypertension
* Right heart catheterization (RHC) hemodynamics with a mean pulmonary arterial pressure \>=20 millimetres of mercury at rest, a pulmonary capillary wedge pressure \<= 15 millimetres of mercury, and a pulmonary vascular resistance \>= 3 woods units
Exclusion Criteria:
* Inability to undergo (non-contrast) Magnetic Resonance Imaging (MRI) testing
* On chronotropic agents (Beta-Blockers, anti-arrhythmic medications, etc.) that could affect the calculation and interpretation of HRV measures
* Conditions that could affect the accuracy of MRI imaging, including a history previously repaired or unrepaired congenital heart defects, ventricular or atrial septal defects, or other anatomic cardiac abnormalities)
* Inability to complete a six-minute walk test
* Currently being on targeted PAH therapy at the time of consent and enrollment
* Thyroid disease, known arrhythmias in the past six months, uncontrolled anemia with a hemoglobin less than 7 grams per deciliter, untreated coronary artery disease or a diagnosis of myocardial infarction in the past 6 months, the presence of a cardiac pacemaker
* Clinically significant lung disease (including pulmonary function testing forced vital capacity \< 60%), a positive ventilation/perfusion scan, uncontrolled sleep apnea not adherent with noninvasive positive pressure ventilation
* Unable to consent, pregnant women, and prisoners.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04451850
Study Brief:
Protocol Section:
NCT04451850