ID

31702

Beskrivning

Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00705133

Länk

https://clinicaltrials.gov/show/NCT00705133

Nyckelord

Versioner (1)
  1. 2018-09-21 2018-09-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT00705133

Engelsk

Eligibility Pulmonary Arterial Hypertension NCT00705133

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
eligible subjects must have ipf and severe pah documented on standard of care right-heart catheterization (rhc) and planned to receive therapy with treprostinil as recommended by the treating physician.
Beskrivning

Idiopathic Pulmonary Fibrosis Catheterization of right heart | Pulmonary arterial hypertension Severe Catheterization of right heart | Treprostinil Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1800706
UMLS CUI [1,2]
C0189896
UMLS CUI [2,1]
C2973725
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0189896
UMLS CUI [3,1]
C1145760
UMLS CUI [3,2]
C1301732
1. all subjects must have high resolution ct scan (hrct) diagnostic of ipf (performed as part of standard of care evaluation) or if available, biopsy proven histological usual interstitial pneumonia (uip).
Beskrivning

Idiopathic Pulmonary Fibrosis High Resolution CT | Usual interstitial pneumonia Biopsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1800706
UMLS CUI [1,2]
C1512457
UMLS CUI [2,1]
C1800706
UMLS CUI [2,2]
C0005558
2. severe pulmonary arterial hypertension defined as a resting mean pulmonary artery pressure (mpap) > 35 mm hg; and pulmonary vascular resistance (pvr) > 3 woods-units; and pulmonary capillary wedge pressure (pcwp) < 18 mm hg by right-heart catheterization (rhc) performed as part of standard of care evaluation.
Beskrivning

Pulmonary arterial hypertension Severe Catheterization of right heart | Mean pulmonary arterial pressure resting | Pulmonary Vascular Resistance Wood units Quantity | Pulmonary Capillary Wedge Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0189896
UMLS CUI [2,1]
C3854605
UMLS CUI [2,2]
C0035253
UMLS CUI [3,1]
C0456261
UMLS CUI [3,2]
C0439525
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C0086879
3. all subjects must be planned to receive treprostinil therapy as recommended by their treating physician.
Beskrivning

Treprostinil Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1145760
UMLS CUI [1,2]
C1301732
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. acute or chronic impairment other than dyspnea (e.g. angina pectoris, intermittent claudication) limiting the ability to perform standard of care six-minute walk tests (6mwt).
Beskrivning

Impairment Limiting 6-Minute Walk Test | Impairment chronic Limiting 6-Minute Walk Test | Exception Dyspnea | Angina Pectoris | Intermittent Claudication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221099
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0430515
UMLS CUI [2,1]
C0221099
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C0430515
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0013404
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0021775
2. six-minute walk distance (6mwd) < 50 meters at screening or baseline standard of care evaluations
Beskrivning

6-Minute Walk Test Meter Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0475209
UMLS CUI [1,3]
C1265611
3. standard of care pulmonary function test (pft) showing forced expiratory volume in one second (fev1)/ forced vital capacity (fvc) ratio < 0.65
Beskrivning

FEV1/FVC ratio Pulmonary function tests

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0429745
UMLS CUI [1,2]
C0024119
4. standard of care pulmonary function test (pft) showing a residual volume >120% predicted
Beskrivning

Percent Predicted Residual Volume Pulmonary function tests

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3828592
UMLS CUI [1,2]
C0024119
5. standard of care high-resolution chest computed tomography (hrct) showing emphysema extent > 30%
Beskrivning

Emphysema Extent Percentage High resolution CT of chest

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034067
UMLS CUI [1,2]
C0439792
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C2318026
6. any investigational therapy as part of a clinical trial for any indication with 30 days before screening
Beskrivning

Therapy, Investigational | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2]
C2348568
7. change in dose of treatment for ipf - investigational agent (gamma interferon-1b, pirfenidone, etanercept, and any other investigational agent intended to treat ipf), corticosteroids, or cytotoxic agents, within 30 days before screening. that is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment.
Beskrivning

Therapeutic procedure Idiopathic Pulmonary Fibrosis | Investigational New Drugs Dose Changed | Interferon gamma-1b | pirfenidone | Etanercept | Adrenal Cortex Hormones | Cytotoxic agent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1800706
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0392747
UMLS CUI [3]
C0021741
UMLS CUI [4]
C0298067
UMLS CUI [5]
C0717758
UMLS CUI [6]
C0001617
UMLS CUI [7]
C0304497
8. current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
Beskrivning

Therapeutic procedure Pulmonary Hypertension | Prostaglandins | Epoprostenol | Iloprost

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0020542
UMLS CUI [2]
C0033554
UMLS CUI [3]
C0033567
UMLS CUI [4]
C0079594
9. change in dose of treatment for pah - (bosentan, sitaxsentan, ambrisentan, tadalafil, sildenafil, vardenafil, calcium channel blockers, nitrates, digitalis), within 30 days before screening. that is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment
Beskrivning

Therapeutic procedure Pulmonary arterial hypertension | Medication dose changed | bosentan | sitaxsentan | ambrisentan | tadalafil | sildenafil | vardenafil | Calcium Channel Blockers | Nitrates | Digitalis preparation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2973725
UMLS CUI [2]
C1608430
UMLS CUI [3]
C0252643
UMLS CUI [4]
C1704271
UMLS CUI [5]
C1176329
UMLS CUI [6]
C1176316
UMLS CUI [7]
C0529793
UMLS CUI [8]
C0971579
UMLS CUI [9]
C0006684
UMLS CUI [10]
C0028125
UMLS CUI [11]
C0304520
10. pulmonary rehabilitation initiated within 30 days of baseline.
Beskrivning

Pulmonary rehabilitation Initiation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0199529
UMLS CUI [1,2]
C1704686
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT00705133

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Idiopathic Pulmonary Fibrosis Catheterization of right heart | Pulmonary arterial hypertension Severe Catheterization of right heart | Treprostinil Planned
Item
eligible subjects must have ipf and severe pah documented on standard of care right-heart catheterization (rhc) and planned to receive therapy with treprostinil as recommended by the treating physician.
boolean
C1800706 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
C2973725 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0189896 (UMLS CUI [2,3])
C1145760 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Idiopathic Pulmonary Fibrosis High Resolution CT | Usual interstitial pneumonia Biopsy
Item
1. all subjects must have high resolution ct scan (hrct) diagnostic of ipf (performed as part of standard of care evaluation) or if available, biopsy proven histological usual interstitial pneumonia (uip).
boolean
C1800706 (UMLS CUI [1,1])
C1512457 (UMLS CUI [1,2])
C1800706 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Pulmonary arterial hypertension Severe Catheterization of right heart | Mean pulmonary arterial pressure resting | Pulmonary Vascular Resistance Wood units Quantity | Pulmonary Capillary Wedge Pressure
Item
2. severe pulmonary arterial hypertension defined as a resting mean pulmonary artery pressure (mpap) > 35 mm hg; and pulmonary vascular resistance (pvr) > 3 woods-units; and pulmonary capillary wedge pressure (pcwp) < 18 mm hg by right-heart catheterization (rhc) performed as part of standard of care evaluation.
boolean
C2973725 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0189896 (UMLS CUI [1,3])
C3854605 (UMLS CUI [2,1])
C0035253 (UMLS CUI [2,2])
C0456261 (UMLS CUI [3,1])
C0439525 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0086879 (UMLS CUI [4])
Treprostinil Planned
Item
3. all subjects must be planned to receive treprostinil therapy as recommended by their treating physician.
boolean
C1145760 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Impairment Limiting 6-Minute Walk Test | Impairment chronic Limiting 6-Minute Walk Test | Exception Dyspnea | Angina Pectoris | Intermittent Claudication
Item
1. acute or chronic impairment other than dyspnea (e.g. angina pectoris, intermittent claudication) limiting the ability to perform standard of care six-minute walk tests (6mwt).
boolean
C0221099 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0430515 (UMLS CUI [1,3])
C0221099 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0430515 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0013404 (UMLS CUI [3,2])
C0002962 (UMLS CUI [4])
C0021775 (UMLS CUI [5])
6-Minute Walk Test Meter Quantity
Item
2. six-minute walk distance (6mwd) < 50 meters at screening or baseline standard of care evaluations
boolean
C0430515 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
FEV1/FVC ratio Pulmonary function tests
Item
3. standard of care pulmonary function test (pft) showing forced expiratory volume in one second (fev1)/ forced vital capacity (fvc) ratio < 0.65
boolean
C0429745 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Percent Predicted Residual Volume Pulmonary function tests
Item
4. standard of care pulmonary function test (pft) showing a residual volume >120% predicted
boolean
C3828592 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Emphysema Extent Percentage High resolution CT of chest
Item
5. standard of care high-resolution chest computed tomography (hrct) showing emphysema extent > 30%
boolean
C0034067 (UMLS CUI [1,1])
C0439792 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C2318026 (UMLS CUI [1,4])
Therapy, Investigational | Study Subject Participation Status
Item
6. any investigational therapy as part of a clinical trial for any indication with 30 days before screening
boolean
C0949266 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Therapeutic procedure Idiopathic Pulmonary Fibrosis | Investigational New Drugs Dose Changed | Interferon gamma-1b | pirfenidone | Etanercept | Adrenal Cortex Hormones | Cytotoxic agent
Item
7. change in dose of treatment for ipf - investigational agent (gamma interferon-1b, pirfenidone, etanercept, and any other investigational agent intended to treat ipf), corticosteroids, or cytotoxic agents, within 30 days before screening. that is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment.
boolean
C0087111 (UMLS CUI [1,1])
C1800706 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0021741 (UMLS CUI [3])
C0298067 (UMLS CUI [4])
C0717758 (UMLS CUI [5])
C0001617 (UMLS CUI [6])
C0304497 (UMLS CUI [7])
Therapeutic procedure Pulmonary Hypertension | Prostaglandins | Epoprostenol | Iloprost
Item
8. current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
boolean
C0087111 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C0033554 (UMLS CUI [2])
C0033567 (UMLS CUI [3])
C0079594 (UMLS CUI [4])
Therapeutic procedure Pulmonary arterial hypertension | Medication dose changed | bosentan | sitaxsentan | ambrisentan | tadalafil | sildenafil | vardenafil | Calcium Channel Blockers | Nitrates | Digitalis preparation
Item
9. change in dose of treatment for pah - (bosentan, sitaxsentan, ambrisentan, tadalafil, sildenafil, vardenafil, calcium channel blockers, nitrates, digitalis), within 30 days before screening. that is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment
boolean
C0087111 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C1608430 (UMLS CUI [2])
C0252643 (UMLS CUI [3])
C1704271 (UMLS CUI [4])
C1176329 (UMLS CUI [5])
C1176316 (UMLS CUI [6])
C0529793 (UMLS CUI [7])
C0971579 (UMLS CUI [8])
C0006684 (UMLS CUI [9])
C0028125 (UMLS CUI [10])
C0304520 (UMLS CUI [11])
Pulmonary rehabilitation Initiation
Item
10. pulmonary rehabilitation initiated within 30 days of baseline.
boolean
C0199529 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
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