ID

15904

Beschrijving

Exploratory, 2-Part Study to Assess Pulsed Inhaled Nitric Oxide on Functional Pulmonary Imaging Parameters in Subjects With WHO Grp 3 Pulmonary Hypertension Associated With COPD on LTOT; ODM derived from: https://clinicaltrials.gov/show/NCT02267655

Link

https://clinicaltrials.gov/show/NCT02267655

Trefwoorden

Versies (1)
  1. 18-06-16 18-06-16 -
Geüploaded op

18 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT02267655

Engels

Eligibility Pulmonary Hypertension NCT02267655

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must meet all of the following inclusion criteria to be enrolled and eligible to participate in the study:
Beschrijving

Inclusion criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
1. a confirmed diagnosis of copd by the global initiative for chronic obstructive lung disease (gold) criteria
Beschrijving

Chronic Obstructive Airway Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0024117
2. pulmonary hypertension determined by one of the following within the past 12 months:
Beschrijving

Pulmonary Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0020542
1. a right heart catheterization (not obtained within ± 7 days of an exacerbation) with an mpap ≥ 25 mmhg, or
Beschrijving

Catheterization of right heart | Exacerbation | Mean pulmonary arterial pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0189896
UMLS CUI [2]
C0235874
UMLS CUI [3]
C3854605
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 ≥
Beschrijving

Echocardiography | Exacerbation | Regurgitant blood flow velocity Tricuspid | Pulmonary artery systolic pressure | Mean pulmonary arterial pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0013516
UMLS CUI [2]
C0235874
UMLS CUI [3,1]
C4072713
UMLS CUI [3,2]
C0443327
UMLS CUI [4]
C0428643
UMLS CUI [5]
C3854605
25 mmhg determined by right heart catheterization will meet this inclusion criteria even with a trv < 2.9 m/s)
Beschrijving

Catheterization of right heart | Inclusion criteria Fulfill | Regurgitant blood flow velocity Tricuspid

Datatype

boolean

Alias
UMLS CUI [1]
C0189896
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C1550543
UMLS CUI [3,1]
C4072713
UMLS CUI [3,2]
C0443327
3. current or former smokers with at least 10 pack-years of tobacco cigarette smoking before study entry
Beschrijving

smoking cigarettes: ____ pack-years history

Datatype

boolean

Alias
UMLS CUI [1]
C2230126
4. age ≥ 40 years, ≤ 80 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
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 ±
Beschrijving

PULMONARY FUNCTION TEST FEV1 post bronchodilator | Forced vital capacity post bronchodilator | Percent predicted FEV1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
UMLS CUI [2,1]
C1287681
UMLS CUI [2,2]
C2599594
UMLS CUI [3]
C0730561
7 days of an exacerbation; otherwise, the test must be performed during screening)
Beschrijving

Exacerbation

Datatype

boolean

Alias
UMLS CUI [1]
C0235874
6. receiving ltot for ≥ 3 months and ≥ 10 hours per day as determined by history
Beschrijving

Long-term oxygen therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0418996
7. females of childbearing potential must have a negative pre-treatment urine pregnancy test
Beschrijving

Childbearing Potential | Urine pregnancy test negative pre treatment

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0430057
UMLS CUI [2,2]
C2709094
8. signed informed consent prior to the initiation of any study mandated procedures or assessments
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who meet any of the following criteria are not eligible for enrollment:
Beschrijving

criteria Following | Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0332282
UMLS CUI [2]
C1550543
1. a diagnosis of asthma or other non-copd respiratory disease, in the opinion of the investigator
Beschrijving

Asthma | Respiration Disorders | Chronic Obstructive Airway Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0024117
2. lack of patency of nares upon physical examination
Beschrijving

Obstruction of nares | Physical Examination

Datatype

boolean

Alias
UMLS CUI [1]
C3687416
UMLS CUI [2]
C0031809
3. experienced during the last month an exacerbation requiring:
Beschrijving

Exacerbation | Requirement Following

Datatype

boolean

Alias
UMLS CUI [1]
C0235874
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0332282
1. start of or increase in systemic oral corticosteroid therapy and/or
Beschrijving

Oral steroid therapy Systemic Start | Oral steroid therapy Systemic Increase

Datatype

boolean

Alias
UMLS CUI [1,1]
C0574135
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0439659
UMLS CUI [2,1]
C0574135
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C0442805
2. hospitalization
Beschrijving

Hospitalization

Datatype

boolean

Alias
UMLS CUI [1]
C0019993
4. left ventricular dysfunction as measured by:
Beschrijving

Ventricular Dysfunction, Left

Datatype

boolean

Alias
UMLS CUI [1]
C0242698
1. screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction [lvef] < 40%), or
Beschrijving

Echocardiography | Left ventricular systolic dysfunction | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0013516
UMLS CUI [2]
C1277187
UMLS CUI [3]
C0428772
2. screening echocardiographic evidence of left ventricular diastolic dysfunction
Beschrijving

Echocardiography | Left ventricular diastolic dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0013516
UMLS CUI [2]
C1273070
> moderate (i.e., > grade 2), or
Beschrijving

Greater Than Moderate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0439093
UMLS CUI [1,2]
C0205081
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
Beschrijving

Pulmonary Capillary Wedge Pressure | Left atrial pressure | Left ventricular end-diastolic pressure level | Cardiac Catheterization | Resolved

Datatype

boolean

Alias
UMLS CUI [1]
C0086879
UMLS CUI [2]
C0456170
UMLS CUI [3]
C0456190
UMLS CUI [4]
C0018795
UMLS CUI [5]
C3714811
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):
Beschrijving

Renal Insufficiency | renal function GFR estimation by MDRD | Kidney Failure

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
UMLS CUI [3]
C0035078
estimated gfrmdrd = 175×scr -1.154×age-0.203 ×1.212 (if black) ×0.742 (if female)
Beschrijving

renal function GFR estimation by MDRD | Creatinine serum Standard | Age | Black | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C2170215
UMLS CUI [2,1]
C0201976
UMLS CUI [2,2]
C1442989
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0005680
UMLS CUI [5]
C0079399
where scr = standardized serum creatinine
Beschrijving

Creatinine serum Standard

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1442989
6. known allergy to contrast media.
Beschrijving

Hypersensitivity Contrast Media

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0009924
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0020542
UMLS CUI [3,1]
C1260873
UMLS CUI [3,2]
C2945599
UMLS CUI [4,1]
C1260873
UMLS CUI [4,2]
C0439093
UMLS CUI [4,3]
C2945599
UMLS CUI [5]
C0003507
UMLS CUI [6]
C0003504
UMLS CUI [7,1]
C0026265
UMLS CUI [7,2]
C0205081
UMLS CUI [8,1]
C0026265
UMLS CUI [8,2]
C0439093
UMLS CUI [8,3]
C0205081
UMLS CUI [9]
C0026269
UMLS CUI [10]
C0026266
UMLS CUI [11,1]
C0026268
UMLS CUI [11,2]
C0231290
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)
Beschrijving

Pulmonary Hypertension Pharmaceutical Preparations | sildenafil | bosentan | Cialis | Viagra | Erectile dysfunction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C0529793
UMLS CUI [3]
C0252643
UMLS CUI [4]
C0967376
UMLS CUI [5]
C0663448
UMLS CUI [6]
C0242350
9. use of investigational drugs or devices within 30 days prior to enrollment into the study
Beschrijving

Investigational New Drugs | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
10. any underlying medical or psychiatric condition that, in the opinion of the investigator, makes the subject an unsuitable candidate for the study
Beschrijving

Comorbidity Study Subject Participation Status Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
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Eligibility Pulmonary Hypertension NCT02267655

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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