ID

15904

Descrição

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

Palavras-chave

Versões (1)
  1. 18/06/2016 18/06/2016 -
Transferido a

18 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT02267655

Inglês

Eligibility Pulmonary Hypertension NCT02267655

1 Formulários  
Inclusion Criteria
Descrição

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:
Descrição

Inclusion criteria Fulfill

Tipo de dados

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
Descrição

Chronic Obstructive Airway Disease

Tipo de dados

boolean

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

Pulmonary Hypertension

Tipo de dados

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
Descrição

Catheterization of right heart | Exacerbation | Mean pulmonary arterial pressure

Tipo de dados

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 ≥
Descrição

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

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

smoking cigarettes: ____ pack-years history

Tipo de dados

boolean

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

Age

Tipo de dados

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 ±
Descrição

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

Tipo de dados

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)
Descrição

Exacerbation

Tipo de dados

boolean

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

Long-term oxygen therapy

Tipo de dados

boolean

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

Childbearing Potential | Urine pregnancy test negative pre treatment

Tipo de dados

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
Descrição

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

criteria Following | Fulfill

Tipo de dados

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
Descrição

Asthma | Respiration Disorders | Chronic Obstructive Airway Disease

Tipo de dados

boolean

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

Obstruction of nares | Physical Examination

Tipo de dados

boolean

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

Exacerbation | Requirement Following

Tipo de dados

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
Descrição

Oral steroid therapy Systemic Start | Oral steroid therapy Systemic Increase

Tipo de dados

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
Descrição

Hospitalization

Tipo de dados

boolean

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

Ventricular Dysfunction, Left

Tipo de dados

boolean

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

Echocardiography | Left ventricular systolic dysfunction | Left ventricular ejection fraction

Tipo de dados

boolean

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

Echocardiography | Left ventricular diastolic dysfunction

Tipo de dados

boolean

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

Greater Than Moderate

Tipo de dados

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
Descrição

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

Tipo de dados

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):
Descrição

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

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Creatinine serum Standard

Tipo de dados

boolean

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

Hypersensitivity Contrast Media

Tipo de dados

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
Descrição

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

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Investigational New Drugs | Investigational Medical Device

Tipo de dados

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
Descrição

Comorbidity Study Subject Participation Status Limited

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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