Pulmonary arterial hypertension
Item
subjects must have a diagnosis of pulmonary arterial hypertension (pah) due to the following:
boolean
C2973725 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension | Heritable pulmonary arterial hypertension | Connective Tissue Disease | Scleroderma, Limited | Diffuse Scleroderma | Mixed Connective Tissue Disease | Lupus Erythematosus, Systemic | Overlap syndrome | Drugs | Toxins | HIV Infection | Congenital Heart Defects Repaired | Atrial Septal Defects | Ventricular Septal Defects | Patent ductus arteriosus | Portopulmonary hypertension Ineligible | Pulmonary Veno-Occlusive Disease Ineligible
Item
a. idiopathic or heritable pah b. pah associated with: i. connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease, systemic lupus erythematosus, or overlap syndrome) ii. drugs or toxins iii. human immunodeficiency virus (hiv) infection iv. congenital heart defects repaired greater than 1 year prior to screening (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) nb: subjects with portopulmonary hypertension and pulmonary veno-occlusive disease are not eligible for the study
boolean
C3203102 (UMLS CUI [1])
C0340543 (UMLS CUI [2])
C0009782 (UMLS CUI [3])
C0748540 (UMLS CUI [4])
C1258104 (UMLS CUI [5])
C0026272 (UMLS CUI [6])
C0024141 (UMLS CUI [7])
C0410000 (UMLS CUI [8])
C0242508 (UMLS CUI [9])
C0040549 (UMLS CUI [10])
C0019693 (UMLS CUI [11])
C0018798 (UMLS CUI [12,1])
C0205340 (UMLS CUI [12,2])
C0018817 (UMLS CUI [13])
C0018818 (UMLS CUI [14])
C0013274 (UMLS CUI [15])
C1868851 (UMLS CUI [16,1])
C1512714 (UMLS CUI [16,2])
C0034091 (UMLS CUI [17,1])
C1512714 (UMLS CUI [17,2])
Diagnosis WHO classification
Item
subject must have a current diagnosis of being in world health organisation (who) functional class ii or iii.
boolean
C0011900 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
Criteria Hemodynamic Fulfill | Catheterization of right heart
Item
subject must meet all of the following haemodynamic criteria by means of a right heart catheterization prior to screening:
boolean
C0243161 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0189896 (UMLS CUI [2])
Mean pulmonary arterial pressure | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure
Item
i. mpap of ≥25 mmhg ii. pvr ≥ 300 dynes/sec/cm5 iii. pcwp or lvedp of ≤12 mmhg if pvr
boolean
C3854605 (UMLS CUI [1])
C0456261 (UMLS CUI [2])
C0086879 (UMLS CUI [3])
C0456190 (UMLS CUI [4])
Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure | Pulmonary Vascular Resistance
Item
≥300 to <500 dyne/sec/cm5 , or pcwp/lvedp ≤ 15 mmhg if pvr ≥500 dynes/sec/cm5
boolean
C0086879 (UMLS CUI [1])
C0456190 (UMLS CUI [2])
C0456261 (UMLS CUI [3])
Able to walk Distance m
Item
subject must walk a distance of ≥125m and ≤500m at the screening visit
boolean
C2712089 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
C0475209 (UMLS CUI [1,3])
Prior Therapy Pulmonary arterial hypertension | Phosphodiesterase 5 inhibitor | Endothelin receptor antagonist | Prostaglandins chronic
Item
subject received previous pah therapy (phosphodiesterase type 5 inhibitor (pde5i), endothelin receptor antagonist (era), chronic prostanoid*) within 4 weeks prior to the screening visit (*chronic prostanoid use is considered >7 days of treatment)
boolean
C1514463 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C1318700 (UMLS CUI [2])
C1134681 (UMLS CUI [3])
C0033554 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
Endothelin receptor antagonist | bosentan | sitaxsentan | Phosphodiesterase 5 inhibitor | sildenafil
Item
subject received era treatment (e.g., bosentan or sitaxentan) or pde5i treatment (e.g. sildenafil) at any time and discontinued due to tolerance issues other than those associated with liver function abnormalities
boolean
C1134681 (UMLS CUI [1])
C0252643 (UMLS CUI [2])
C1704271 (UMLS CUI [3])
C1318700 (UMLS CUI [4])
C0529793 (UMLS CUI [5])
Ambrisentan Discontinued | Tadalafil Discontinued | Letairis Discontinued | Adcirca Discontinued
Item
subjects who have previously discontinued ambrisentan or tadalafil in either another clinical study or commercial product (volibris/letairis or adcirca) for safety or tolerability reasons.
boolean
C1176329 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1176316 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1949323 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C2709986 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])