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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT02603068
Eligibility Criteria:
Inclusion Criteria:
* Voluntarily gives informed consent
* Must meet criteria for lung transplant referral but is not required to be on an active lung transplant list
* Stable and significant diffuse parenchymal lung disease with a diagnosis of interstitial lung disease
* 6MWD greater than or equal to 75 meters
* Right heart catheterization with a mean pulmonary arterial pressure \>= 30 mgHg, pulmonary capillary wedge pressure \<= 15 mmHg and pulmonary vascular resistance \> 240 dynes
* Echo-Doppler examination showing evidence of right ventricular dysfunction and normal left diastolic ventricular function
* Either not receiving any PAH-approved oral therapy, or is receiving monotherapy (ERA, PDE-5I, or riociguat) for \> 60 days and receiving a stable dose for \> 30 days prior to enrollment
* Able to communicate effectively with study personnel and will to be cooperative with protocol requirements
Exclusion Criteria:
* History of repaired or unrepaired congenital heart disease
* Received prostanoid therapy in the past 30 days, or has shown an intolerance or lack of efficacy to prostanoid therapy resulting in discontinuation or inability to titrate prostacyclins
* Diagnosis of sarcoidosis
* History of thromboembolic disease
* Chronic renal insufficiency
* Pregnancy or lactating
* Currently receiving an investigational drug, has an investigational device in place, or has participated in an investigational drug or device study within 30 days prior to Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02603068
Study Brief:
Protocol Section:
NCT02603068