ID

31502

Description

A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01028651

Link

https://clinicaltrials.gov/show/NCT01028651

Keywords

Versions (1)
  1. 8/29/18 8/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Portopulmonary Hypertension NCT01028651

English

Eligibility Portopulmonary Hypertension NCT01028651

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. confirmed severe poph documented on standard of care right-heart catheterization (rhc) with a plan to initiate treprostinil therapy, as recommended by the treating physician state within 30 days.
Description

Portopulmonary hypertension Severe | Standard of Care Catheterization of right heart | Treprostinil Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1868851
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0189896
UMLS CUI [3,1]
C1145760
UMLS CUI [3,2]
C1301732
2. have portal hypertension.
Description

Hypertension, Portal

Data type

boolean

Alias
UMLS CUI [1]
C0020541
3. be otherwise suitable candidates for olt.
Description

Patients Appropriate Orthotopic liver transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0400447
4. treprostinil therapy must be recommended by the treating physician per standard of care.
Description

Treprostinil Standard of Care Recommended

Data type

boolean

Alias
UMLS CUI [1,1]
C1145760
UMLS CUI [1,2]
C2936643
UMLS CUI [1,3]
C0034866
5. be nyha class ii, iii, or iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
6. have pulmonary capillary wedge pressure (pcw) < 18 mmhg and transpulmonary gradient (tpg) ≥ 15 mmhg severe pah is defined as a resting mean pulmonary artery pressure (mpa) > 25 mmhg and pulmonary vascular resistance (pvr) ≥ 3 wood-units by right-heart catheterization (rhc) performed as part of standard of care evaluation within 30 days of enrollment
Description

Pulmonary Capillary Wedge Pressure | Other Coding | Pulmonary arterial hypertension Severe | Pulmonary artery mean pressure Resting | Pulmonary Vascular Resistance Wood units | Catheterization of right heart | Standard of Care Evaluation

Data type

boolean

Alias
UMLS CUI [1]
C0086879
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0428645
UMLS CUI [4,2]
C0035253
UMLS CUI [5,1]
C0456261
UMLS CUI [5,2]
C0439525
UMLS CUI [6]
C0189896
UMLS CUI [7,1]
C2936643
UMLS CUI [7,2]
C1261322
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. be taking any investigational therapy as part of a clinical trial for any indication within 30 days of enrollment.
Description

Study Subject Participation Status | Indication Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0949266
2. be receiving any vasodilator treatment for pulmonary hypertension (i.e. bosentan, sitaxsentan, ambrisentan, sildenafil, tadalafil, epoprostenol, beraprost, iloprost, inhaled treprostinil) at the time of enrollment.
Description

Vasodilator Agents Pulmonary Hypertension | bosentan | sitaxsentan | ambrisentan | sildenafil | tadalafil | Epoprostenol | beraprost | Iloprost | Treprostinil Inhaled

Data type

boolean

Alias
UMLS CUI [1,1]
C0042402
UMLS CUI [1,2]
C0020542
UMLS CUI [2]
C0252643
UMLS CUI [3]
C1704271
UMLS CUI [4]
C1176329
UMLS CUI [5]
C0529793
UMLS CUI [6]
C1176316
UMLS CUI [7]
C0033567
UMLS CUI [8]
C0053336
UMLS CUI [9]
C0079594
UMLS CUI [10,1]
C1145760
UMLS CUI [10,2]
C0001559
3. exhibit renal failure requiring hemodialysis.
Description

Kidney Failure Requirement Hemodialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019004
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Similar models

Eligibility Portopulmonary Hypertension NCT01028651

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients must:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Portopulmonary hypertension Severe | Standard of Care Catheterization of right heart | Treprostinil Planned
Item
1. confirmed severe poph documented on standard of care right-heart catheterization (rhc) with a plan to initiate treprostinil therapy, as recommended by the treating physician state within 30 days.
boolean
C1868851 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0189896 (UMLS CUI [2,2])
C1145760 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Hypertension, Portal
Item
2. have portal hypertension.
boolean
C0020541 (UMLS CUI [1])
Patients Appropriate Orthotopic liver transplant
Item
3. be otherwise suitable candidates for olt.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0400447 (UMLS CUI [1,3])
Treprostinil Standard of Care Recommended
Item
4. treprostinil therapy must be recommended by the treating physician per standard of care.
boolean
C1145760 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C0034866 (UMLS CUI [1,3])
New York Heart Association Classification
Item
5. be nyha class ii, iii, or iv
boolean
C1275491 (UMLS CUI [1])
Pulmonary Capillary Wedge Pressure | Other Coding | Pulmonary arterial hypertension Severe | Pulmonary artery mean pressure Resting | Pulmonary Vascular Resistance Wood units | Catheterization of right heart | Standard of Care Evaluation
Item
6. have pulmonary capillary wedge pressure (pcw) < 18 mmhg and transpulmonary gradient (tpg) ≥ 15 mmhg severe pah is defined as a resting mean pulmonary artery pressure (mpa) > 25 mmhg and pulmonary vascular resistance (pvr) ≥ 3 wood-units by right-heart catheterization (rhc) performed as part of standard of care evaluation within 30 days of enrollment
boolean
C0086879 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C2973725 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0428645 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
C0456261 (UMLS CUI [5,1])
C0439525 (UMLS CUI [5,2])
C0189896 (UMLS CUI [6])
C2936643 (UMLS CUI [7,1])
C1261322 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients must not:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Study Subject Participation Status | Indication Investigational Therapy
Item
1. be taking any investigational therapy as part of a clinical trial for any indication within 30 days of enrollment.
boolean
C2348568 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
Vasodilator Agents Pulmonary Hypertension | bosentan | sitaxsentan | ambrisentan | sildenafil | tadalafil | Epoprostenol | beraprost | Iloprost | Treprostinil Inhaled
Item
2. be receiving any vasodilator treatment for pulmonary hypertension (i.e. bosentan, sitaxsentan, ambrisentan, sildenafil, tadalafil, epoprostenol, beraprost, iloprost, inhaled treprostinil) at the time of enrollment.
boolean
C0042402 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C0252643 (UMLS CUI [2])
C1704271 (UMLS CUI [3])
C1176329 (UMLS CUI [4])
C0529793 (UMLS CUI [5])
C1176316 (UMLS CUI [6])
C0033567 (UMLS CUI [7])
C0053336 (UMLS CUI [8])
C0079594 (UMLS CUI [9])
C1145760 (UMLS CUI [10,1])
C0001559 (UMLS CUI [10,2])
Kidney Failure Requirement Hemodialysis
Item
3. exhibit renal failure requiring hemodialysis.
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
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