ID

15895

Description

The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study; ODM derived from: https://clinicaltrials.gov/show/NCT02253394

Link

https://clinicaltrials.gov/show/NCT02253394

Keywords

Versions (1)
  1. 6/17/16 6/17/16 -
Uploaded on

June 17, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Pulmonary Arterial Hypertension NCT02253394

English

Eligibility Pulmonary Arterial Hypertension NCT02253394

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. voluntarily gives informed consent to participate in the study.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. right heart catheterization demonstrating conventional mean pulmonary artery pressure (mpap) >25, pulmonary vascular resistance (pvr) >3.0 wood units, pulmonary capillary wedge pressure (pcwp) <16 mmhg within one year of enrollment
Description

Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0189896
UMLS CUI [2]
C3854605
UMLS CUI [3]
C0456261
UMLS CUI [4]
C0086879
3. subject is 16-75 years of age at screening.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. diagnosis of symptomatic idiopathic or heritable pah, pah associated with connective tissue disease (ctd), pah associated with repaired/unrepaired congenital systemic-to-pulmonary shunt, portopulmonary hypertension or pah associated with hiv infection.
Description

Idiopathic pulmonary arterial hypertension Symptomatic | Familial primary pulmonary hypertension | Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt | Pulmonary arterial hypertension associated with portal hypertension | Pulmonary arterial hypertension associated with HIV infection

Data type

boolean

Alias
UMLS CUI [1,1]
C3203102
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0340543
UMLS CUI [3]
C3697982
UMLS CUI [4]
C3698160
UMLS CUI [5]
C1868851
UMLS CUI [6]
C3697673
5. new york heart association functional class ii or iii
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
6. stable therapy with ambrisentan 5 or 10 mg every day for > 90 days.
Description

ambrisentan | Therapeutic procedure Stable

Data type

boolean

Alias
UMLS CUI [1]
C1176329
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205360
7. baseline 6-minute walk distance 50-450m
Description

6 Minute Walk Functional Test Walking distance

Data type

boolean

Alias
UMLS CUI [1,1]
C3900196
UMLS CUI [1,2]
C0429886
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. substantial primary lung disease
Description

Lung disease Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205225
forced expiratory volume at one second (fev-1)/forced vital capacity (fvc) <0.6 and fev-1 <70% predicted
Description

FEV1 | Forced vital capacity | Percent predicted FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C1287681
UMLS CUI [3]
C0730561
diffusing capacity of lung for carbon monoxide (dlco) <30% predicted
Description

Carbon Monoxide Diffusing Capability Test

Data type

boolean

Alias
UMLS CUI [1]
C1516251
pulmonary fibrosis
Description

Pulmonary Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0034069
2. left ventricular ejection fraction < 50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
3. pulmonary capillary wedge pressure > 16 mm hg
Description

Pulmonary Capillary Wedge Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0086879
4. aortic valve disease
Description

Aortic valve disorder

Data type

boolean

Alias
UMLS CUI [1]
C1260873
5. ischemic heart disease
Description

Myocardial Ischemia

Data type

boolean

Alias
UMLS CUI [1]
C0151744
6. systemic hypotension (sbp <90 mm hg)
Description

Hypotension Systemic | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020649
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0871470
7. co-existing treatment with other endothelin receptor antagonists or prostacyclin analogues
Description

Concomitant Therapy | Endothelin receptor antagonist | Prostacyclin Analogue

Data type

boolean

Alias
UMLS CUI [1]
C1707479
UMLS CUI [2]
C1134681
UMLS CUI [3,1]
C0033567
UMLS CUI [3,2]
C0243071
8. new york heart association functional class iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
9. chronic thromboembolic pulmonary hypertension
Description

Chronic thromboembolic pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C2363973
10. known or suspected pulmonary veno-occlusive disease
Description

Pulmonary Veno-Occlusive Disease

Data type

boolean

Alias
UMLS CUI [1]
C0034091
11. serum creatinine >2.0 mg/dl in women, serum creatinine >2.5 mg/dl in men
Description

Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
12. baseline serum potassium >5.0 milliequivalent (meq)/l
Description

Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0302353
13. participation in ongoing drug/intervention-based clinical trial
Description

Study Subject Participation Status | Investigational New Drugs | Surgical and medical procedures

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C1948041
14. pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
15. unable to provide consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
Back to the top of the page

Similar models

Eligibility Pulmonary Arterial Hypertension NCT02253394

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
1. voluntarily gives informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure
Item
2. right heart catheterization demonstrating conventional mean pulmonary artery pressure (mpap) >25, pulmonary vascular resistance (pvr) >3.0 wood units, pulmonary capillary wedge pressure (pcwp) <16 mmhg within one year of enrollment
boolean
C0189896 (UMLS CUI [1])
C3854605 (UMLS CUI [2])
C0456261 (UMLS CUI [3])
C0086879 (UMLS CUI [4])
Age
Item
3. subject is 16-75 years of age at screening.
boolean
C0001779 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension Symptomatic | Familial primary pulmonary hypertension | Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt | Pulmonary arterial hypertension associated with portal hypertension | Pulmonary arterial hypertension associated with HIV infection
Item
4. diagnosis of symptomatic idiopathic or heritable pah, pah associated with connective tissue disease (ctd), pah associated with repaired/unrepaired congenital systemic-to-pulmonary shunt, portopulmonary hypertension or pah associated with hiv infection.
boolean
C3203102 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0340543 (UMLS CUI [2])
C3697982 (UMLS CUI [3])
C3698160 (UMLS CUI [4])
C1868851 (UMLS CUI [5])
C3697673 (UMLS CUI [6])
New York Heart Association Classification
Item
5. new york heart association functional class ii or iii
boolean
C1275491 (UMLS CUI [1])
ambrisentan | Therapeutic procedure Stable
Item
6. stable therapy with ambrisentan 5 or 10 mg every day for > 90 days.
boolean
C1176329 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
6 Minute Walk Functional Test Walking distance
Item
7. baseline 6-minute walk distance 50-450m
boolean
C3900196 (UMLS CUI [1,1])
C0429886 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Lung disease Primary
Item
1. substantial primary lung disease
boolean
C0024115 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
FEV1 | Forced vital capacity | Percent predicted FEV1
Item
forced expiratory volume at one second (fev-1)/forced vital capacity (fvc) <0.6 and fev-1 <70% predicted
boolean
C0748133 (UMLS CUI [1])
C1287681 (UMLS CUI [2])
C0730561 (UMLS CUI [3])
Carbon Monoxide Diffusing Capability Test
Item
diffusing capacity of lung for carbon monoxide (dlco) <30% predicted
boolean
C1516251 (UMLS CUI [1])
Pulmonary Fibrosis
Item
pulmonary fibrosis
boolean
C0034069 (UMLS CUI [1])
Left ventricular ejection fraction
Item
2. left ventricular ejection fraction < 50%
boolean
C0428772 (UMLS CUI [1])
Pulmonary Capillary Wedge Pressure
Item
3. pulmonary capillary wedge pressure > 16 mm hg
boolean
C0086879 (UMLS CUI [1])
Aortic valve disorder
Item
4. aortic valve disease
boolean
C1260873 (UMLS CUI [1])
Myocardial Ischemia
Item
5. ischemic heart disease
boolean
C0151744 (UMLS CUI [1])
Hypotension Systemic | Systolic Pressure
Item
6. systemic hypotension (sbp <90 mm hg)
boolean
C0020649 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
Concomitant Therapy | Endothelin receptor antagonist | Prostacyclin Analogue
Item
7. co-existing treatment with other endothelin receptor antagonists or prostacyclin analogues
boolean
C1707479 (UMLS CUI [1])
C1134681 (UMLS CUI [2])
C0033567 (UMLS CUI [3,1])
C0243071 (UMLS CUI [3,2])
New York Heart Association Classification
Item
8. new york heart association functional class iv
boolean
C1275491 (UMLS CUI [1])
Chronic thromboembolic pulmonary hypertension
Item
9. chronic thromboembolic pulmonary hypertension
boolean
C2363973 (UMLS CUI [1])
Pulmonary Veno-Occlusive Disease
Item
10. known or suspected pulmonary veno-occlusive disease
boolean
C0034091 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
11. serum creatinine >2.0 mg/dl in women, serum creatinine >2.5 mg/dl in men
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Serum potassium measurement
Item
12. baseline serum potassium >5.0 milliequivalent (meq)/l
boolean
C0302353 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Surgical and medical procedures
Item
13. participation in ongoing drug/intervention-based clinical trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1948041 (UMLS CUI [3])
Pregnancy
Item
14. pregnancy
boolean
C0032961 (UMLS CUI [1])
Informed Consent Unable
Item
15. unable to provide consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial