ID

31708

Descrição

Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.; ODM derived from: https://clinicaltrials.gov/show/NCT00705588

Link

https://clinicaltrials.gov/show/NCT00705588

Palavras-chave

Versões (1)
  1. 22/09/2018 22/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT00705588

Inglês

Eligibility Pulmonary Arterial Hypertension NCT00705588

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): mean pap >25mmhg at rest or >30mmhg with exercise, by a pcwp< 15mmhg and by pvr >3 wood units.
Descrição

Pulmonary arterial hypertension Right heart Catheter Data | Mean pulmonary arterial pressure At rest | Mean pulmonary arterial pressure Exercise induced | Pulmonary Capillary Wedge Pressure | Pulmonary Vascular Resistance Wood units Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0225808
UMLS CUI [1,3]
C0085590
UMLS CUI [1,4]
C1511726
UMLS CUI [2,1]
C3854605
UMLS CUI [2,2]
C0443144
UMLS CUI [3,1]
C3854605
UMLS CUI [3,2]
C0239313
UMLS CUI [4]
C0086879
UMLS CUI [5,1]
C0456261
UMLS CUI [5,2]
C0439525
UMLS CUI [5,3]
C1265611
currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).
Descrição

Prostanoid Stable | Epoprostenol Intravenous | Iloprost Inhalation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033554
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0033567
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C0079594
UMLS CUI [3,2]
C0205535
willing and able to participate in all study follow-up procedures.
Descrição

Participation Follow-up

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3274571
new york heart association (nyha) class ii-iv.
Descrição

New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275491
six minute walking distance between 100-450 meters at the baseline assessment.
Descrição

6-Minute Walk Test Meter Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0475209
UMLS CUI [1,3]
C1265611
women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
Descrição

Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Test

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
patients with congenital heart disease are eligible for inclusion.
Descrição

Congenital heart disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0152021
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
functional class nyha class i.
Descrição

New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275491
pah due to chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (vc or fev1 < 60% of predicted) or chronic hypoxia.
Descrição

Pulmonary arterial hypertension Due to Chronic pulmonary thromboembolism | Pulmonary hypertension due to left heart disease | Pulmonary arterial hypertension Due to Chronic lung disease | Percentage of predicted vital capacity | Percent predicted FEV1 | Pulmonary arterial hypertension Due to HYPOXIA CHRONIC

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3873396
UMLS CUI [2]
C3532326
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0746102
UMLS CUI [4]
C2919340
UMLS CUI [5]
C0730561
UMLS CUI [6,1]
C2973725
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0745190
acute intercurrent illness requiring hospital admission in the month proceeding screening.
Descrição

Comorbidity Hospitalization Required

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1708385
any non-pah medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.
Descrição

Medical condition Interferes with Evaluation Endpoints | Musculoskeletal Diseases | Exception Pulmonary arterial hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C2349179
UMLS CUI [2]
C0026857
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2973725
any uncontrolled or terminal non-pah medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
Descrição

Medical condition Uncontrolled Interferes with Completion of clinical trial | Condition terminal Interferes with Completion of clinical trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2732579
UMLS CUI [2,1]
C2051439
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
concomitant therapy with drugs known to interact adversely with the study drug.
Descrição

Adverse drug interaction Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678798
UMLS CUI [1,2]
C0013230
chronic renal failure - creatinine clearance <50ml/min as calculated with the cockcroft equation.
Descrição

Kidney Failure, Chronic | Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C2711451
current participation in another clinical trial.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
pregnancy or planned pregnancy during the study period.
Descrição

Pregnancy | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT00705588

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary arterial hypertension Right heart Catheter Data | Mean pulmonary arterial pressure At rest | Mean pulmonary arterial pressure Exercise induced | Pulmonary Capillary Wedge Pressure | Pulmonary Vascular Resistance Wood units Quantity
Item
all patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): mean pap >25mmhg at rest or >30mmhg with exercise, by a pcwp< 15mmhg and by pvr >3 wood units.
boolean
C2973725 (UMLS CUI [1,1])
C0225808 (UMLS CUI [1,2])
C0085590 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C3854605 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C3854605 (UMLS CUI [3,1])
C0239313 (UMLS CUI [3,2])
C0086879 (UMLS CUI [4])
C0456261 (UMLS CUI [5,1])
C0439525 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Prostanoid Stable | Epoprostenol Intravenous | Iloprost Inhalation
Item
currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).
boolean
C0033554 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0033567 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0079594 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
Participation Follow-up
Item
willing and able to participate in all study follow-up procedures.
boolean
C0679823 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
New York Heart Association Classification
Item
new york heart association (nyha) class ii-iv.
boolean
C1275491 (UMLS CUI [1])
6-Minute Walk Test Meter Quantity
Item
six minute walking distance between 100-450 meters at the baseline assessment.
boolean
C0430515 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Test
Item
women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
Congenital heart disease
Item
patients with congenital heart disease are eligible for inclusion.
boolean
C0152021 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
New York Heart Association Classification
Item
functional class nyha class i.
boolean
C1275491 (UMLS CUI [1])
Pulmonary arterial hypertension Due to Chronic pulmonary thromboembolism | Pulmonary hypertension due to left heart disease | Pulmonary arterial hypertension Due to Chronic lung disease | Percentage of predicted vital capacity | Percent predicted FEV1 | Pulmonary arterial hypertension Due to HYPOXIA CHRONIC
Item
pah due to chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (vc or fev1 < 60% of predicted) or chronic hypoxia.
boolean
C2973725 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3873396 (UMLS CUI [1,3])
C3532326 (UMLS CUI [2])
C2973725 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0746102 (UMLS CUI [3,3])
C2919340 (UMLS CUI [4])
C0730561 (UMLS CUI [5])
C2973725 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0745190 (UMLS CUI [6,3])
Comorbidity Hospitalization Required
Item
acute intercurrent illness requiring hospital admission in the month proceeding screening.
boolean
C0009488 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Medical condition Interferes with Evaluation Endpoints | Musculoskeletal Diseases | Exception Pulmonary arterial hypertension
Item
any non-pah medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C2349179 (UMLS CUI [1,4])
C0026857 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C2973725 (UMLS CUI [3,2])
Medical condition Uncontrolled Interferes with Completion of clinical trial | Condition terminal Interferes with Completion of clinical trial
Item
any uncontrolled or terminal non-pah medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
C2051439 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Adverse drug interaction Investigational New Drugs
Item
concomitant therapy with drugs known to interact adversely with the study drug.
boolean
C0678798 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Kidney Failure, Chronic | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
chronic renal failure - creatinine clearance <50ml/min as calculated with the cockcroft equation.
boolean
C0022661 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Study Subject Participation Status
Item
current participation in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
pregnancy or planned pregnancy during the study period.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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