ID

36979

Description

GS-4997 in Adults With Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02234141

Link

https://clinicaltrials.gov/show/NCT02234141

Keywords

Versions (2)
  1. 6/25/19 6/25/19 -
  2. 9/17/21 9/17/21 -
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See clinicaltrials.gov

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June 25, 2019

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Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT02234141

English

Eligibility Pulmonary Arterial Hypertension NCT02234141

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of idiopathic pulmonary arterial hypertension (ipah), heritable pulmonary arterial hypertension (hpah), drug- and toxin-induced pah, or pah associated with connective tissue disease, hiv infection, or congenital heart defects (repaired greater than 1 year prior to screening)
Description

Idiopathic pulmonary hypertension | Heritable pulmonary hypertension | Drug- and Toxin-Induced Pulmonary Arterial Hypertension | Pulmonary arterial hypertension Associated with Connective Tissue Disease | Pulmonary arterial hypertension Associated with HIV Infection | Pulmonary arterial hypertension Associated with Congenital Heart Defects

Data type

boolean

Alias
UMLS CUI [1]
C0152171
UMLS CUI [2]
C0340543
UMLS CUI [3]
C4055116
UMLS CUI [4,1]
C2973725
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0009782
UMLS CUI [5,1]
C2973725
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0019693
UMLS CUI [6,1]
C2973725
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C0018798
meet all of the following hemodynamic criteria by means of a screening right heart catheterization (rhc) completed prior to randomization:
Description

Criteria Hemodynamic Fulfill | Catheterization of right heart Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C1550543
UMLS CUI [2,1]
C0189896
UMLS CUI [2,2]
C0205197
mean pulmonary artery pressure (mpap) of ≥ 25 mm hg
Description

Mean pulmonary arterial pressure

Data type

boolean

Alias
UMLS CUI [1]
C3854605
pulmonary vascular resistance (pvr) ≥ 400 dyne•sec/cm^5
Description

Pulmonary Vascular Resistance

Data type

boolean

Alias
UMLS CUI [1]
C0456261
pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) of ≤ 12 mm hg if pvr ≥ 400 and < 500 dynes•sec/cm^5, or pcwp/lvedp ≤ 15 mm hg if pvr ≥ 500 dynes•sec/cm^5
Description

Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure level | Pulmonary Vascular Resistance

Data type

boolean

Alias
UMLS CUI [1]
C0086879
UMLS CUI [2]
C0456190
UMLS CUI [3]
C0456261
be able to walk a distance of at least 100 m
Description

Able to walk Distance

Data type

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0429886
have world health organization (who) functional class ii or iii symptoms
Description

WHO classification Functional Status Class Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C4267671
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
UMLS CUI [1,4]
C1457887
meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening, performed with or without bronchodilation:
Description

Criteria Fulfill | Pulmonary function tests | Bronchodilation | Bronchodilation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [2]
C0024119
UMLS CUI [3]
C3537072
UMLS CUI [4,1]
C3537072
UMLS CUI [4,2]
C0332197
forced expiratory volume in one second (fev1) ≥ 55% of predicted normal
Description

Percent predicted FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0730561
fev1:forced vital capacity (fvc) ratio ≥ 0.60
Description

FEV1/FVC ratio

Data type

boolean

Alias
UMLS CUI [1]
C0429745
receiving treatment with one or more drugs approved for pah for ≥ 12 consecutive weeks and at stable dose for ≥ 8 consecutive weeks
Description

Pharmacotherapy Pulmonary arterial hypertension | Pharmaceutical Preparations Quantity | Pharmaceutical Preparations Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2973725
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of pah associated with significant venous or capillary involvement (pcwp > 15 mm hg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects
Description

Pulmonary arterial hypertension | Involvement Venous | Involvement capillary | Pulmonary Capillary Wedge Pressure | Pulmonary capillary hemangiomatosis | Hypertension, Portal | Congenital Heart Defects Without Repair

Data type

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0348013
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0006901
UMLS CUI [4]
C0086879
UMLS CUI [5]
C0340548
UMLS CUI [6]
C0020541
UMLS CUI [7,1]
C0018798
UMLS CUI [7,2]
C0332288
UMLS CUI [7,3]
C4319951
pulmonary hypertension (ph) belonging to groups 2 to 5 of the 2013 nice classification
Description

Pulmonary hypertension Classification Group Number

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0008902
UMLS CUI [1,3]
C0441833
UMLS CUI [1,4]
C0237753
left ventricular ejection fraction (lvef) ≤ 40% or clinically significant ischemic, valvular or constrictive heart disease
Description

Left ventricular ejection fraction | Myocardial Ischemia | Heart valve disease | CONSTRICTIVE HEART DISEASE

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0151744
UMLS CUI [3]
C0018824
UMLS CUI [4]
C0742769
uncontrolled hypertension (≥ 180/110 mm hg) at screening
Description

Uncontrolled hypertension | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
end stage renal disease (receiving peritoneal dialysis, hemodialysis, or status after renal transplantation)
Description

Kidney Failure, Chronic | Peritoneal Dialysis | Hemodialysis | Status post Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0031139
UMLS CUI [3]
C0019004
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0022671
severe liver disease (child-pugh class c, with or without cirrhosis)
Description

Liver disease Severe Child-Pugh Classification | Liver Cirrhosis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2347612
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0332197
individuals may be rescreened one additional time with prior notification to and approval by the sponsor.
Description

Screening Repeated allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0683607
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT02234141

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Idiopathic pulmonary hypertension | Heritable pulmonary hypertension | Drug- and Toxin-Induced Pulmonary Arterial Hypertension | Pulmonary arterial hypertension Associated with Connective Tissue Disease | Pulmonary arterial hypertension Associated with HIV Infection | Pulmonary arterial hypertension Associated with Congenital Heart Defects
Item
diagnosis of idiopathic pulmonary arterial hypertension (ipah), heritable pulmonary arterial hypertension (hpah), drug- and toxin-induced pah, or pah associated with connective tissue disease, hiv infection, or congenital heart defects (repaired greater than 1 year prior to screening)
boolean
C0152171 (UMLS CUI [1])
C0340543 (UMLS CUI [2])
C4055116 (UMLS CUI [3])
C2973725 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0009782 (UMLS CUI [4,3])
C2973725 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0019693 (UMLS CUI [5,3])
C2973725 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0018798 (UMLS CUI [6,3])
Criteria Hemodynamic Fulfill | Catheterization of right heart Completed
Item
meet all of the following hemodynamic criteria by means of a screening right heart catheterization (rhc) completed prior to randomization:
boolean
C0243161 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0189896 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Mean pulmonary arterial pressure
Item
mean pulmonary artery pressure (mpap) of ≥ 25 mm hg
boolean
C3854605 (UMLS CUI [1])
Pulmonary Vascular Resistance
Item
pulmonary vascular resistance (pvr) ≥ 400 dyne•sec/cm^5
boolean
C0456261 (UMLS CUI [1])
Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure level | Pulmonary Vascular Resistance
Item
pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) of ≤ 12 mm hg if pvr ≥ 400 and < 500 dynes•sec/cm^5, or pcwp/lvedp ≤ 15 mm hg if pvr ≥ 500 dynes•sec/cm^5
boolean
C0086879 (UMLS CUI [1])
C0456190 (UMLS CUI [2])
C0456261 (UMLS CUI [3])
Able to walk Distance
Item
be able to walk a distance of at least 100 m
boolean
C2712089 (UMLS CUI [1,1])
C0429886 (UMLS CUI [1,2])
WHO classification Functional Status Class Symptoms
Item
have world health organization (who) functional class ii or iii symptoms
boolean
C4267671 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Criteria Fulfill | Pulmonary function tests | Bronchodilation | Bronchodilation Absent
Item
meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening, performed with or without bronchodilation:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0024119 (UMLS CUI [2])
C3537072 (UMLS CUI [3])
C3537072 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Percent predicted FEV1
Item
forced expiratory volume in one second (fev1) ≥ 55% of predicted normal
boolean
C0730561 (UMLS CUI [1])
FEV1/FVC ratio
Item
fev1:forced vital capacity (fvc) ratio ≥ 0.60
boolean
C0429745 (UMLS CUI [1])
Pharmacotherapy Pulmonary arterial hypertension | Pharmaceutical Preparations Quantity | Pharmaceutical Preparations Dose Stable
Item
receiving treatment with one or more drugs approved for pah for ≥ 12 consecutive weeks and at stable dose for ≥ 8 consecutive weeks
boolean
C0013216 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Pulmonary arterial hypertension | Involvement Venous | Involvement capillary | Pulmonary Capillary Wedge Pressure | Pulmonary capillary hemangiomatosis | Hypertension, Portal | Congenital Heart Defects Without Repair
Item
diagnosis of pah associated with significant venous or capillary involvement (pcwp > 15 mm hg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects
boolean
C2973725 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0348013 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0006901 (UMLS CUI [3,2])
C0086879 (UMLS CUI [4])
C0340548 (UMLS CUI [5])
C0020541 (UMLS CUI [6])
C0018798 (UMLS CUI [7,1])
C0332288 (UMLS CUI [7,2])
C4319951 (UMLS CUI [7,3])
Pulmonary hypertension Classification Group Number
Item
pulmonary hypertension (ph) belonging to groups 2 to 5 of the 2013 nice classification
boolean
C0020542 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Left ventricular ejection fraction | Myocardial Ischemia | Heart valve disease | CONSTRICTIVE HEART DISEASE
Item
left ventricular ejection fraction (lvef) ≤ 40% or clinically significant ischemic, valvular or constrictive heart disease
boolean
C0428772 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
C0018824 (UMLS CUI [3])
C0742769 (UMLS CUI [4])
Uncontrolled hypertension | Blood pressure determination
Item
uncontrolled hypertension (≥ 180/110 mm hg) at screening
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Kidney Failure, Chronic | Peritoneal Dialysis | Hemodialysis | Status post Kidney Transplantation
Item
end stage renal disease (receiving peritoneal dialysis, hemodialysis, or status after renal transplantation)
boolean
C0022661 (UMLS CUI [1])
C0031139 (UMLS CUI [2])
C0019004 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0022671 (UMLS CUI [4,2])
Liver disease Severe Child-Pugh Classification | Liver Cirrhosis Absent
Item
severe liver disease (child-pugh class c, with or without cirrhosis)
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Screening Repeated allowed
Item
individuals may be rescreened one additional time with prior notification to and approval by the sponsor.
boolean
C0220908 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
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