Idiopathic Pulmonary Fibrosis Catheterization of right heart | Pulmonary arterial hypertension Severe Catheterization of right heart | Treprostinil Planned
Item
eligible subjects must have ipf and severe pah documented on standard of care right-heart catheterization (rhc) and planned to receive therapy with treprostinil as recommended by the treating physician.
boolean
C1800706 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
C2973725 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0189896 (UMLS CUI [2,3])
C1145760 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Idiopathic Pulmonary Fibrosis High Resolution CT | Usual interstitial pneumonia Biopsy
Item
1. all subjects must have high resolution ct scan (hrct) diagnostic of ipf (performed as part of standard of care evaluation) or if available, biopsy proven histological usual interstitial pneumonia (uip).
boolean
C1800706 (UMLS CUI [1,1])
C1512457 (UMLS CUI [1,2])
C1800706 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Pulmonary arterial hypertension Severe Catheterization of right heart | Mean pulmonary arterial pressure resting | Pulmonary Vascular Resistance Wood units Quantity | Pulmonary Capillary Wedge Pressure
Item
2. severe pulmonary arterial hypertension defined as a resting mean pulmonary artery pressure (mpap) > 35 mm hg; and pulmonary vascular resistance (pvr) > 3 woods-units; and pulmonary capillary wedge pressure (pcwp) < 18 mm hg by right-heart catheterization (rhc) performed as part of standard of care evaluation.
boolean
C2973725 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0189896 (UMLS CUI [1,3])
C3854605 (UMLS CUI [2,1])
C0035253 (UMLS CUI [2,2])
C0456261 (UMLS CUI [3,1])
C0439525 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0086879 (UMLS CUI [4])
Treprostinil Planned
Item
3. all subjects must be planned to receive treprostinil therapy as recommended by their treating physician.
boolean
C1145760 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Impairment Limiting 6-Minute Walk Test | Impairment chronic Limiting 6-Minute Walk Test | Exception Dyspnea | Angina Pectoris | Intermittent Claudication
Item
1. acute or chronic impairment other than dyspnea (e.g. angina pectoris, intermittent claudication) limiting the ability to perform standard of care six-minute walk tests (6mwt).
boolean
C0221099 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0430515 (UMLS CUI [1,3])
C0221099 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0430515 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0013404 (UMLS CUI [3,2])
C0002962 (UMLS CUI [4])
C0021775 (UMLS CUI [5])
6-Minute Walk Test Meter Quantity
Item
2. six-minute walk distance (6mwd) < 50 meters at screening or baseline standard of care evaluations
boolean
C0430515 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
FEV1/FVC ratio Pulmonary function tests
Item
3. standard of care pulmonary function test (pft) showing forced expiratory volume in one second (fev1)/ forced vital capacity (fvc) ratio < 0.65
boolean
C0429745 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Percent Predicted Residual Volume Pulmonary function tests
Item
4. standard of care pulmonary function test (pft) showing a residual volume >120% predicted
boolean
C3828592 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Emphysema Extent Percentage High resolution CT of chest
Item
5. standard of care high-resolution chest computed tomography (hrct) showing emphysema extent > 30%
boolean
C0034067 (UMLS CUI [1,1])
C0439792 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C2318026 (UMLS CUI [1,4])
Therapy, Investigational | Study Subject Participation Status
Item
6. any investigational therapy as part of a clinical trial for any indication with 30 days before screening
boolean
C0949266 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Therapeutic procedure Idiopathic Pulmonary Fibrosis | Investigational New Drugs Dose Changed | Interferon gamma-1b | pirfenidone | Etanercept | Adrenal Cortex Hormones | Cytotoxic agent
Item
7. change in dose of treatment for ipf - investigational agent (gamma interferon-1b, pirfenidone, etanercept, and any other investigational agent intended to treat ipf), corticosteroids, or cytotoxic agents, within 30 days before screening. that is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment.
boolean
C0087111 (UMLS CUI [1,1])
C1800706 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0021741 (UMLS CUI [3])
C0298067 (UMLS CUI [4])
C0717758 (UMLS CUI [5])
C0001617 (UMLS CUI [6])
C0304497 (UMLS CUI [7])
Therapeutic procedure Pulmonary Hypertension | Prostaglandins | Epoprostenol | Iloprost
Item
8. current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
boolean
C0087111 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C0033554 (UMLS CUI [2])
C0033567 (UMLS CUI [3])
C0079594 (UMLS CUI [4])
Therapeutic procedure Pulmonary arterial hypertension | Medication dose changed | bosentan | sitaxsentan | ambrisentan | tadalafil | sildenafil | vardenafil | Calcium Channel Blockers | Nitrates | Digitalis preparation
Item
9. change in dose of treatment for pah - (bosentan, sitaxsentan, ambrisentan, tadalafil, sildenafil, vardenafil, calcium channel blockers, nitrates, digitalis), within 30 days before screening. that is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment
boolean
C0087111 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C1608430 (UMLS CUI [2])
C0252643 (UMLS CUI [3])
C1704271 (UMLS CUI [4])
C1176329 (UMLS CUI [5])
C1176316 (UMLS CUI [6])
C0529793 (UMLS CUI [7])
C0971579 (UMLS CUI [8])
C0006684 (UMLS CUI [9])
C0028125 (UMLS CUI [10])
C0304520 (UMLS CUI [11])
Pulmonary rehabilitation Initiation
Item
10. pulmonary rehabilitation initiated within 30 days of baseline.
boolean
C0199529 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])