Inclusion criteria Fulfill
Item
subjects must meet all of the following inclusion criteria to be enrolled and eligible to participate in the study:
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Chronic Obstructive Airway Disease
Item
1. a confirmed diagnosis of copd by the global initiative for chronic obstructive lung disease (gold) criteria
boolean
C0024117 (UMLS CUI [1])
Pulmonary Hypertension
Item
2. pulmonary hypertension determined by one of the following within the past 12 months:
boolean
C0020542 (UMLS CUI [1])
Catheterization of right heart | Exacerbation | Mean pulmonary arterial pressure
Item
1. a right heart catheterization (not obtained within ± 7 days of an exacerbation) with an mpap ≥ 25 mmhg, or
boolean
C0189896 (UMLS CUI [1])
C0235874 (UMLS CUI [2])
C3854605 (UMLS CUI [3])
Echocardiography | Exacerbation | Regurgitant blood flow velocity Tricuspid | Pulmonary artery systolic pressure | Mean pulmonary arterial pressure
Item
2. an echocardiogram (not obtained within ± 7 days of an exacerbation) with a trv ≥ 2.9 m/s or spap ≥ 38 mmhg (note: a subject with an acceptable mpap ≥
boolean
C0013516 (UMLS CUI [1])
C0235874 (UMLS CUI [2])
C4072713 (UMLS CUI [3,1])
C0443327 (UMLS CUI [3,2])
C0428643 (UMLS CUI [4])
C3854605 (UMLS CUI [5])
Catheterization of right heart | Inclusion criteria Fulfill | Regurgitant blood flow velocity Tricuspid
Item
25 mmhg determined by right heart catheterization will meet this inclusion criteria even with a trv < 2.9 m/s)
boolean
C0189896 (UMLS CUI [1])
C1512693 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
C4072713 (UMLS CUI [3,1])
C0443327 (UMLS CUI [3,2])
smoking cigarettes: ____ pack-years history
Item
3. current or former smokers with at least 10 pack-years of tobacco cigarette smoking before study entry
boolean
C2230126 (UMLS CUI [1])
Age
Item
4. age ≥ 40 years, ≤ 80 years
boolean
C0001779 (UMLS CUI [1])
PULMONARY FUNCTION TEST FEV1 post bronchodilator | Forced vital capacity post bronchodilator | Percent predicted FEV1
Item
5. a post-bronchodilatory fev1/fvc < 0.7 and a fev1 < 60% predicted (values obtained within 6 months prior to screening can be used unless obtained within ±
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
C1287681 (UMLS CUI [2,1])
C2599594 (UMLS CUI [2,2])
C0730561 (UMLS CUI [3])
Exacerbation
Item
7 days of an exacerbation; otherwise, the test must be performed during screening)
boolean
C0235874 (UMLS CUI [1])
Long-term oxygen therapy
Item
6. receiving ltot for ≥ 3 months and ≥ 10 hours per day as determined by history
boolean
C0418996 (UMLS CUI [1])
Childbearing Potential | Urine pregnancy test negative pre treatment
Item
7. females of childbearing potential must have a negative pre-treatment urine pregnancy test
boolean
C3831118 (UMLS CUI [1])
C0430057 (UMLS CUI [2,1])
C2709094 (UMLS CUI [2,2])
Informed consent
Item
8. signed informed consent prior to the initiation of any study mandated procedures or assessments
boolean
C0021430 (UMLS CUI [1])
criteria Following | Fulfill
Item
subjects who meet any of the following criteria are not eligible for enrollment:
boolean
C0243161 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1550543 (UMLS CUI [2])
Asthma | Respiration Disorders | Chronic Obstructive Airway Disease
Item
1. a diagnosis of asthma or other non-copd respiratory disease, in the opinion of the investigator
boolean
C0004096 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
Obstruction of nares | Physical Examination
Item
2. lack of patency of nares upon physical examination
boolean
C3687416 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
Exacerbation | Requirement Following
Item
3. experienced during the last month an exacerbation requiring:
boolean
C0235874 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
Oral steroid therapy Systemic Start | Oral steroid therapy Systemic Increase
Item
1. start of or increase in systemic oral corticosteroid therapy and/or
boolean
C0574135 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0574135 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0442805 (UMLS CUI [2,3])
Hospitalization
Item
2. hospitalization
boolean
C0019993 (UMLS CUI [1])
Ventricular Dysfunction, Left
Item
4. left ventricular dysfunction as measured by:
boolean
C0242698 (UMLS CUI [1])
Echocardiography | Left ventricular systolic dysfunction | Left ventricular ejection fraction
Item
1. screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction [lvef] < 40%), or
boolean
C0013516 (UMLS CUI [1])
C1277187 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
Echocardiography | Left ventricular diastolic dysfunction
Item
2. screening echocardiographic evidence of left ventricular diastolic dysfunction
boolean
C0013516 (UMLS CUI [1])
C1273070 (UMLS CUI [2])
Greater Than Moderate
Item
> moderate (i.e., > grade 2), or
boolean
C0439093 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
Pulmonary Capillary Wedge Pressure | Left atrial pressure | Left ventricular end-diastolic pressure level | Cardiac Catheterization | Resolved
Item
3. any history of pulmonary capillary wedge pressure (pcwp), left atrial pressure (lap) or left ventricular end diastolic pressure (lvedp) > 18 mmhg as measured during cardiac catheterization within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization
boolean
C0086879 (UMLS CUI [1])
C0456170 (UMLS CUI [2])
C0456190 (UMLS CUI [3])
C0018795 (UMLS CUI [4])
C3714811 (UMLS CUI [5])
Renal Insufficiency | renal function GFR estimation by MDRD | Kidney Failure
Item
5. renal impairment (i.e., an estimated gfrmdrd < 60 ml/min/1.73 m2) or history of renal failure using the equation (levey et al., 2007):
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
renal function GFR estimation by MDRD | Creatinine serum Standard | Age | Black | Gender
Item
estimated gfrmdrd = 175×scr -1.154×age-0.203 ×1.212 (if black) ×0.742 (if female)
boolean
C2170215 (UMLS CUI [1])
C0201976 (UMLS CUI [2,1])
C1442989 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0005680 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
Creatinine serum Standard
Item
where scr = standardized serum creatinine
boolean
C0201976 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
Hypersensitivity Contrast Media
Item
6. known allergy to contrast media.
boolean
C0020517 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
Heart valve disease Clinical Significance | Pulmonary Hypertension | Aortic valve disorder Mild | Aortic valve disorder Greater Than Mild | Aortic Valve Stenosis | Aortic Valve Insufficiency | Diseases of mitral valve Moderate | Diseases of mitral valve Greater Than Moderate | Mitral Valve Stenosis | Mitral Valve Insufficiency | Replacement of mitral valve Status post
Item
7. clinically significant valvular heart disease that may contribute to ph, including mild or greater aortic valvular disease (aortic stenosis or regurgitation) and/or moderate or greater mitral valve disease (mitral stenosis or regurgitation), or status post mitral valve replacement
boolean
C0018824 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0020542 (UMLS CUI [2])
C1260873 (UMLS CUI [3,1])
C2945599 (UMLS CUI [3,2])
C1260873 (UMLS CUI [4,1])
C0439093 (UMLS CUI [4,2])
C2945599 (UMLS CUI [4,3])
C0003507 (UMLS CUI [5])
C0003504 (UMLS CUI [6])
C0026265 (UMLS CUI [7,1])
C0205081 (UMLS CUI [7,2])
C0026265 (UMLS CUI [8,1])
C0439093 (UMLS CUI [8,2])
C0205081 (UMLS CUI [8,3])
C0026269 (UMLS CUI [9])
C0026266 (UMLS CUI [10])
C0026268 (UMLS CUI [11,1])
C0231290 (UMLS CUI [11,2])
Pulmonary Hypertension Pharmaceutical Preparations | sildenafil | bosentan | Cialis | Viagra | Erectile dysfunction
Item
8. use within 30 days of screening or current use of approved ph medications such as sildenafil or bosentan (use of cialis® or viagra® for erectile dysfunction is permitted)
boolean
C0020542 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0529793 (UMLS CUI [2])
C0252643 (UMLS CUI [3])
C0967376 (UMLS CUI [4])
C0663448 (UMLS CUI [5])
C0242350 (UMLS CUI [6])
Investigational New Drugs | Investigational Medical Device
Item
9. use of investigational drugs or devices within 30 days prior to enrollment into the study
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Comorbidity Study Subject Participation Status Limited
Item
10. any underlying medical or psychiatric condition that, in the opinion of the investigator, makes the subject an unsuitable candidate for the study
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])