ID

44623

Description

Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1); ODM derived from: https://clinicaltrials.gov/show/NCT00617305

Link

https://clinicaltrials.gov/show/NCT00617305

Keywords

Versions (3)
  1. 9/21/18 9/21/18 -
  2. 9/21/18 9/21/18 -
  3. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT00617305

English

Eligibility Pulmonary Arterial Hypertension NCT00617305

1 forms  
Criteria
Description

Criteria

must be between 16 and 75 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
must weigh at least 40 kg;
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
have a current diagnosis of idiopathic pah, familial pah, or pah that is primarily due to connective tissue disease, congenital heart defects, drug or toxin use, or human immunodeficiency virus (hiv);
Description

Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital heart disease | Pulmonary arterial hypertension induced by drug | Pulmonary arterial hypertension induced by toxin | Pulmonary arterial hypertension associated with HIV infection

Data type

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C1701939
UMLS CUI [3]
C3697982
UMLS CUI [4]
C3697119
UMLS CUI [5]
C0340544
UMLS CUI [6]
C3697954
UMLS CUI [7]
C3697673
have who functional class iii symptoms;
Description

Symptoms WHO classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C4267671
be receiving sildenafil or tadalafil monotherapy for the treatment of pah for at least the past 12 weeks and at a stable dose for at least 8 consecutive weeks;
Description

Sildenafil Dose Stable | Tadalafil Dose Stable | Therapeutic procedure Pulmonary arterial hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0529793
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1176316
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2973725
meet all of the following hemodynamic criteria by means of a right heart catheterization: mpap of at least 25 mmhg; pvr of at least 400 dyne*sec/cm5; pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) of not more than 15 mmhg;
Description

Criteria Hemodynamic Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0189896
UMLS CUI [2]
C3854605
UMLS CUI [3]
C0456261
UMLS CUI [4]
C0086879
UMLS CUI [5]
C1171395
meet all of the following pulmonary function test criteria no more than 12 weeks before the screening visit: total lung capacity at least 60% of predicted normal and forced expiratory volume in 1 second of at least 65% of predicted normal;
Description

Pulmonary function tests Criteria | Percent Predicted Total Lung Capacity | Percent predicted FEV1

Data type

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0243161
UMLS CUI [2]
C3828589
UMLS CUI [3]
C0730561
able to walk at least 150 meters during the screening 6-minute walk test (6mwt);
Description

Able to walk Meter Quantity 6-Minute Walk Test

Data type

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0475209
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0430515
if receiving calcium channel blockers or 5-hydroxy-3-methylglutaryl-coenzyme a reductase inhibitors (i.e., statins) must be on stable therapy for at least 4 weeks;
Description

Calcium Channel Blockers Stable | Statins Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0006684
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0360714
UMLS CUI [2,2]
C0205360
if diagnosed with hiv, must have stable disease status.
Description

HIV Infection Stable status

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0205360
selected exclusion criteria:
Description

Exclusion Criteria selected

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1707391
have a current pulmonary hypertension diagnosis other than idiopathic pah, familial pah, or pah that is primarily due to connective tissue disease, congenital heart defects, drug or toxin use, or hiv;
Description

Pulmonary Hypertension | Exception Idiopathic pulmonary arterial hypertension | Exception Familial pulmonary arterial hypertension | Exception Pulmonary arterial hypertension associated with connective tissue disease | Exception Pulmonary arterial hypertension associated with congenital heart disease | Exception Pulmonary arterial hypertension induced by drug | Exception Pulmonary arterial hypertension induced by toxin | Exception Pulmonary arterial hypertension associated with HIV infection

Data type

boolean

Alias
UMLS CUI [1]
C0020542
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3203102
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1701939
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3697982
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C3697119
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0340544
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C3697954
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C3697673
have 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
have received chronic prostanoid or endothelin receptor antagonist (era) therapy (eg, bosentan, sitaxsentan) within the past 12 weeks;
Description

Prostanoid chronic | Endothelin receptor antagonist chronic | bosentan | sitaxsentan

Data type

boolean

Alias
UMLS CUI [1,1]
C0033554
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C1134681
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0252643
UMLS CUI [4]
C1704271
have discontinued era treatment for any adverse reaction other than those associated with liver function test abnormalities;
Description

Endothelin receptor antagonist Discontinued Due to Adverse reactions | Exception Abnormal liver function tests

Data type

boolean

Alias
UMLS CUI [1,1]
C1134681
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0559546
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0151766
have received iv inotropes within 2 weeks;
Description

Inotropic agent Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
have a serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) value that is greater than 2.0x the upper limit of normal.
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT00617305

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
must be between 16 and 75 years of age;
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
must weigh at least 40 kg;
boolean
C0005910 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital heart disease | Pulmonary arterial hypertension induced by drug | Pulmonary arterial hypertension induced by toxin | Pulmonary arterial hypertension associated with HIV infection
Item
have a current diagnosis of idiopathic pah, familial pah, or pah that is primarily due to connective tissue disease, congenital heart defects, drug or toxin use, or human immunodeficiency virus (hiv);
boolean
C3203102 (UMLS CUI [1])
C1701939 (UMLS CUI [2])
C3697982 (UMLS CUI [3])
C3697119 (UMLS CUI [4])
C0340544 (UMLS CUI [5])
C3697954 (UMLS CUI [6])
C3697673 (UMLS CUI [7])
Symptoms WHO classification
Item
have who functional class iii symptoms;
boolean
C1457887 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
Sildenafil Dose Stable | Tadalafil Dose Stable | Therapeutic procedure Pulmonary arterial hypertension
Item
be receiving sildenafil or tadalafil monotherapy for the treatment of pah for at least the past 12 weeks and at a stable dose for at least 8 consecutive weeks;
boolean
C0529793 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1176316 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C2973725 (UMLS CUI [3,2])
Criteria Hemodynamic Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure measurement
Item
meet all of the following hemodynamic criteria by means of a right heart catheterization: mpap of at least 25 mmhg; pvr of at least 400 dyne*sec/cm5; pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) of not more than 15 mmhg;
boolean
C0243161 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0189896 (UMLS CUI [1,3])
C3854605 (UMLS CUI [2])
C0456261 (UMLS CUI [3])
C0086879 (UMLS CUI [4])
C1171395 (UMLS CUI [5])
Pulmonary function tests Criteria | Percent Predicted Total Lung Capacity | Percent predicted FEV1
Item
meet all of the following pulmonary function test criteria no more than 12 weeks before the screening visit: total lung capacity at least 60% of predicted normal and forced expiratory volume in 1 second of at least 65% of predicted normal;
boolean
C0024119 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C3828589 (UMLS CUI [2])
C0730561 (UMLS CUI [3])
Able to walk Meter Quantity 6-Minute Walk Test
Item
able to walk at least 150 meters during the screening 6-minute walk test (6mwt);
boolean
C2712089 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0430515 (UMLS CUI [1,4])
Calcium Channel Blockers Stable | Statins Stable
Item
if receiving calcium channel blockers or 5-hydroxy-3-methylglutaryl-coenzyme a reductase inhibitors (i.e., statins) must be on stable therapy for at least 4 weeks;
boolean
C0006684 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0360714 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
HIV Infection Stable status
Item
if diagnosed with hiv, must have stable disease status.
boolean
C0019693 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Exclusion Criteria selected
Item
selected exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1707391 (UMLS CUI [1,2])
Pulmonary Hypertension | Exception Idiopathic pulmonary arterial hypertension | Exception Familial pulmonary arterial hypertension | Exception Pulmonary arterial hypertension associated with connective tissue disease | Exception Pulmonary arterial hypertension associated with congenital heart disease | Exception Pulmonary arterial hypertension induced by drug | Exception Pulmonary arterial hypertension induced by toxin | Exception Pulmonary arterial hypertension associated with HIV infection
Item
have a current pulmonary hypertension diagnosis other than idiopathic pah, familial pah, or pah that is primarily due to connective tissue disease, congenital heart defects, drug or toxin use, or hiv;
boolean
C0020542 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3203102 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1701939 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C3697982 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C3697119 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0340544 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C3697954 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C3697673 (UMLS CUI [8,2])
Left ventricular ejection fraction | Myocardial Ischemia | Heart valve disease | CONSTRICTIVE HEART DISEASE
Item
have 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])
Prostanoid chronic | Endothelin receptor antagonist chronic | bosentan | sitaxsentan
Item
have received chronic prostanoid or endothelin receptor antagonist (era) therapy (eg, bosentan, sitaxsentan) within the past 12 weeks;
boolean
C0033554 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1134681 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0252643 (UMLS CUI [3])
C1704271 (UMLS CUI [4])
Endothelin receptor antagonist Discontinued Due to Adverse reactions | Exception Abnormal liver function tests
Item
have discontinued era treatment for any adverse reaction other than those associated with liver function test abnormalities;
boolean
C1134681 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0559546 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0151766 (UMLS CUI [2,2])
Inotropic agent Intravenous
Item
have received iv inotropes within 2 weeks;
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
have a serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) value that is greater than 2.0x the upper limit of normal.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
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