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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT02536534
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients with a diagnosis of Pulmonary Arterial Hypertension (PAH); or inoperable, persistent or recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH),
* Age ≥ 18 years,
* Baseline 6 Minute Walk Distance (6MWD) a minimum of 250 meters or maximum 450 meters, (ensure significant Pulmonary Hypertension(PH) without limiting their participation in the trial)
* WHO Functional Class II or III,
* Clinically stable patient defined as within the last 12 months (minimum of 3 months) prior to enrollment, there was no:
* decline in World Health Organization (WHO) Function class or,
* decline in 6MWD by 15% or,
* change of oral PAH/CTEPH therapy (may have flexible diuretics/anticoagulation) or,
* Introduction of parenteral Prostacyclin Analog (PCA) treatment.
* Patients provide written informed consent, are able to understand and follow instructions.
Exclusion Criteria:
* Hypersensitivity to nickel (present in the clasp of the FitBit Flex's band),
* Medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator,
* Enrolled in pulmonary rehabilitation program within last 6 months,
* Participating in an interventional study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02536534
Study Brief:
Protocol Section:
NCT02536534