ID

36976

Description

Effects of Oral Sildenafil on Mortality in Adults With PAH; ODM derived from: https://clinicaltrials.gov/show/NCT02060487

Link

https://clinicaltrials.gov/show/NCT02060487

Keywords

Versions (1)
  1. 6/25/19 6/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT02060487

English

Eligibility Pulmonary Arterial Hypertension NCT02060487

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects ≥ 18 <75 years of age with any of the following conditions:
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
idiopathic primary pulmonary arterial hypertension (ipah)
Description

Idiopathic pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0152171
pah secondary to connective tissue disease
Description

Pulmonary arterial hypertension Secondary to Connective Tissue Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0009782
pah with surgical repair (at least 5 years previously) of atrial septal defect (asd),ventricular septal defect (vsd), patent ductus arteriosus (pda) and aorto-pulmonary window
Description

Pulmonary arterial hypertension | Atrioseptoplasty | Ventricular Septal Defects | Patent ductus arteriosus | Aortopulmonary Septal Defect

Data type

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2]
C0189965
UMLS CUI [3]
C0018818
UMLS CUI [4]
C0013274
UMLS CUI [5]
C0003516
pah diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
Description

Pulmonary arterial hypertension | Catheterization of right heart

Data type

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2]
C0189896
functional class ii-iv; baseline 6mwd ≥ 50 m.
Description

Class Functional | 6-Minute Walk Test Distance

Data type

boolean

Alias
UMLS CUI [1,1]
C0456387
UMLS CUI [1,2]
C0205245
UMLS CUI [2,1]
C0430515
UMLS CUI [2,2]
C0429886
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
Description

Valvular disease Stage | Exception Tricuspid Valve Insufficiency | Exception Pulmonary Valve Insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C1306673
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0040961
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0034088
history of cardiac arrest, respiratory arrest, hemodynamic collapse, cpr, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
Description

Cardiac Arrest | Respiratory arrest | Collapse Hemodynamic | Cardiopulmonary Resuscitation | Tachycardia, Ventricular | Ventricular Fibrillation | ATRIAL FIBRILLATION UNCONTROLLED

Data type

boolean

Alias
UMLS CUI [1]
C0018790
UMLS CUI [2]
C0162297
UMLS CUI [3,1]
C0344329
UMLS CUI [3,2]
C0019010
UMLS CUI [4]
C0007203
UMLS CUI [5]
C0042514
UMLS CUI [6]
C0042510
UMLS CUI [7]
C0741284
history of pulmonary embolism; history of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (copd) or scleroderma) with impairment of lung function
Description

Pulmonary Embolism | Chronic lung disease | Restrictive lung disease | Chronic Obstructive Airway Disease | Scleroderma | Pulmonary function impairment

Data type

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2]
C0746102
UMLS CUI [3]
C0085581
UMLS CUI [4]
C0024117
UMLS CUI [5]
C0011644
UMLS CUI [6]
C0858943
no prior long term treatment with pde-5 inhibitors
Description

Phosphodiesterase 5 inhibitor Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C1318700
UMLS CUI [1,2]
C0443252
treatment with bosentan or riociguat within 3 months of randomization
Description

bosentan | riociguat

Data type

boolean

Alias
UMLS CUI [1]
C0252643
UMLS CUI [2]
C2717561
current treatment with nitrates or nitric oxide
Description

Nitrates | Nitric Oxide

Data type

boolean

Alias
UMLS CUI [1]
C0028125
UMLS CUI [2]
C0028128
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT02060487

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subjects ≥ 18 <75 years of age with any of the following conditions:
boolean
C0001779 (UMLS CUI [1])
Idiopathic pulmonary hypertension
Item
idiopathic primary pulmonary arterial hypertension (ipah)
boolean
C0152171 (UMLS CUI [1])
Pulmonary arterial hypertension Secondary to Connective Tissue Diseases
Item
pah secondary to connective tissue disease
boolean
C2973725 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0009782 (UMLS CUI [1,3])
Pulmonary arterial hypertension | Atrioseptoplasty | Ventricular Septal Defects | Patent ductus arteriosus | Aortopulmonary Septal Defect
Item
pah with surgical repair (at least 5 years previously) of atrial septal defect (asd),ventricular septal defect (vsd), patent ductus arteriosus (pda) and aorto-pulmonary window
boolean
C2973725 (UMLS CUI [1])
C0189965 (UMLS CUI [2])
C0018818 (UMLS CUI [3])
C0013274 (UMLS CUI [4])
C0003516 (UMLS CUI [5])
Pulmonary arterial hypertension | Catheterization of right heart
Item
pah diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
boolean
C2973725 (UMLS CUI [1])
C0189896 (UMLS CUI [2])
Class Functional | 6-Minute Walk Test Distance
Item
functional class ii-iv; baseline 6mwd ≥ 50 m.
boolean
C0456387 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0430515 (UMLS CUI [2,1])
C0429886 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Valvular disease Stage | Exception Tricuspid Valve Insufficiency | Exception Pulmonary Valve Insufficiency
Item
significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
boolean
C3258293 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0040961 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0034088 (UMLS CUI [3,2])
Cardiac Arrest | Respiratory arrest | Collapse Hemodynamic | Cardiopulmonary Resuscitation | Tachycardia, Ventricular | Ventricular Fibrillation | ATRIAL FIBRILLATION UNCONTROLLED
Item
history of cardiac arrest, respiratory arrest, hemodynamic collapse, cpr, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
boolean
C0018790 (UMLS CUI [1])
C0162297 (UMLS CUI [2])
C0344329 (UMLS CUI [3,1])
C0019010 (UMLS CUI [3,2])
C0007203 (UMLS CUI [4])
C0042514 (UMLS CUI [5])
C0042510 (UMLS CUI [6])
C0741284 (UMLS CUI [7])
Pulmonary Embolism | Chronic lung disease | Restrictive lung disease | Chronic Obstructive Airway Disease | Scleroderma | Pulmonary function impairment
Item
history of pulmonary embolism; history of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (copd) or scleroderma) with impairment of lung function
boolean
C0034065 (UMLS CUI [1])
C0746102 (UMLS CUI [2])
C0085581 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0011644 (UMLS CUI [5])
C0858943 (UMLS CUI [6])
Phosphodiesterase 5 inhibitor Long-term
Item
no prior long term treatment with pde-5 inhibitors
boolean
C1318700 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
bosentan | riociguat
Item
treatment with bosentan or riociguat within 3 months of randomization
boolean
C0252643 (UMLS CUI [1])
C2717561 (UMLS CUI [2])
Nitrates | Nitric Oxide
Item
current treatment with nitrates or nitric oxide
boolean
C0028125 (UMLS CUI [1])
C0028128 (UMLS CUI [2])
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