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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT03617458
Eligibility Criteria:
Inclusion Criteria:• Adults aged 18 or older.
* Diagnosed with idiopathic, heritable, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
* Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
* Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan.
* WHO Functional Class I-III
* Ambulatory
Exclusion Criteria:
* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity
* Pregnancy
* Diagnosis of PAH etiology other than idiopathic, heritable, or associated with drugs or toxins
* FEV1\> or = 65% predicted AND normal chest imaging
* WHO Functional class IV heart failure
* Requirement of \> 1 diuretic adjustment in the prior 30 days
* Preferred form of activity is not measured by an activity tracker (swimming, ice skating, stair master, or activities on wheels such as bicycling or rollerblading)
* Type I diabetes mellitus
* Prior diagnosis of cirrhosis
* Untreated hypo- or hyper-thyroidism
* estimated glomerular filtration rate (eGFR) by modification of diet in renal disease (MDRD) \<60 milliliters per minute (mL/min)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03617458
Study Brief:
Protocol Section:
NCT03617458