Sponsoring company: United Therapeutics Corporation
Disease states: interstitial lung disease (ILD), pulmonary hypertension (PH), PH-ILD
This study aims to observe and capture demographic characteristics, treatment patterns, and clinical outcomes for patients with PH-ILD to enhance understanding of the disease and treatment. The study will employ four cohorts; three of which will include patients with PH-ILD and one consisting of ILD patients at risk of developing PH. Data collection will occur every six or 12 months unless the data is available via standard of care, following patients for up to five years.
Assessments include pulmonary function tests including diffusing capacity of the lungs for carbon monoxide; high-resolution computed tomography; vital signs; 6-Minute Walk Test; blood draw for plasma N-terminal pro-BNP concentration, genetics analysis, biomarker analysis; echocardiography; EuroQoL 5 Dimension 5 Level Questionnaire; King's Brief ILD Questionnaire; emPHasis-10 Questionnaire; Living with PF Questionnaire; Therapy Administration Questionnaire; health care resource utilization; current medications and rehabilitation; WHO functional class; transplant status; survival data; and RHC.
CLINICALTRIALS.GOV LINK »