ID

15895

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02253394

Stichworte

Versionen (1)
  1. 17.06.16 17.06.16 -
Hochgeladen am

17. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT02253394

Englisch

Eligibility Pulmonary Arterial Hypertension NCT02253394

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Informed consent

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Age

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

New York Heart Association Classification

Datentyp

boolean

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

ambrisentan | Therapeutic procedure Stable

Datentyp

boolean

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

6 Minute Walk Functional Test Walking distance

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. substantial primary lung disease
Beschreibung

Lung disease Primary

Datentyp

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
Beschreibung

FEV1 | Forced vital capacity | Percent predicted FEV1

Datentyp

boolean

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

Carbon Monoxide Diffusing Capability Test

Datentyp

boolean

Alias
UMLS CUI [1]
C1516251
pulmonary fibrosis
Beschreibung

Pulmonary Fibrosis

Datentyp

boolean

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

Left ventricular ejection fraction

Datentyp

boolean

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

Pulmonary Capillary Wedge Pressure

Datentyp

boolean

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

Aortic valve disorder

Datentyp

boolean

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

Myocardial Ischemia

Datentyp

boolean

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

Hypotension Systemic | Systolic Pressure

Datentyp

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
Beschreibung

Concomitant Therapy | Endothelin receptor antagonist | Prostacyclin Analogue

Datentyp

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
Beschreibung

New York Heart Association Classification

Datentyp

boolean

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

Chronic thromboembolic pulmonary hypertension

Datentyp

boolean

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

Pulmonary Veno-Occlusive Disease

Datentyp

boolean

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

Creatinine measurement, serum | Gender

Datentyp

boolean

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

Serum potassium measurement

Datentyp

boolean

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

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

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Pulmonary Arterial Hypertension NCT02253394

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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