ID

28376

Descrição

Safety Study of CD-NP in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00557661

Link

https://clinicaltrials.gov/show/NCT00557661

Palavras-chave

Versões (1)
  1. 09/01/2018 09/01/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

9 de janeiro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00557661

Inglês

Eligibility Congestive Heart Failure NCT00557661

1 Formulários  
Criteria
Descrição

Criteria

male or female ≥18 years of age diagnosed with nyha class iii or iv heart failure in the last six months
Descrição

Age | Heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
female patients must be post-menopausal or surgically sterile
Descrição

Postmenopausal state | Female Sterilization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
diagnosed heart failure with left ventricular ejection fraction <40% obtained within the prior 6 months with at least one symptoms or signs of volume overload
Descrição

Heart failure | Left ventricular ejection fraction | Volume overload Sign or Symptom Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0428772
UMLS CUI [3,1]
C0546817
UMLS CUI [3,2]
C3540840
UMLS CUI [3,3]
C1265611
key exclusion criteria:
Descrição

Exclusion Criteria Main

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
women who are pregnant, breast-feeding or of child-bearing potential
Descrição

Pregnancy | Breast Feeding | Childbearing Potential

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
clinically unstable patients
Descrição

Patients Unstable Clinical

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205210
major surgical procedures within 30 days of entry
Descrição

Major surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
febrile temp > 100 degrees f)
Descrição

Temperature febrile Degrees fahrenheit

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
UMLS CUI [1,3]
C0456628
symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry
Descrição

Carotid disease Symptomatic | Carotid Stenosis Critical | Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0741975
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0007282
UMLS CUI [2,2]
C1511545
UMLS CUI [3]
C0038454
currently on iv vasoactive support (e.g., heart transplant candidate)
Descrição

Vasoactive agent Intravenous | Heart Transplantation Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0597639
UMLS CUI [1,2]
C1522726
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C0205539
history of unexplained syncope within the past 3 months
Descrição

Syncope Unknown

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0039070
UMLS CUI [1,2]
C0439673
history of organ transplantation
Descrição

Organ Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029216
comorbidities such as clinically significant cardiac valvular stenosis, aortic valvular disease, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, infiltrative disease, uncorrected congenital heart disease, acute coronary syndrome, restrictive heart failure, or any other condition which, in the opinion of the investigator, would prevent a patient's participation in the study.
Descrição

Comorbidity | Heart valve stenosis | Aortic valve disorder | Restrictive cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Pericarditis, Constrictive | Primary pulmonary hypertension | Disease Infiltrating | Congenital heart disease uncorrected | Acute Coronary Syndrome | Restrictive heart failure | Condition Study Subject Participation Status Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0264878
UMLS CUI [3]
C1260873
UMLS CUI [4]
C0007196
UMLS CUI [5]
C0007194
UMLS CUI [6]
C0031048
UMLS CUI [7]
C0152171
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C0332448
UMLS CUI [9,1]
C0152021
UMLS CUI [9,2]
C4072785
UMLS CUI [10]
C0948089
UMLS CUI [11]
C1832374
UMLS CUI [12,1]
C0348080
UMLS CUI [12,2]
C2348568
UMLS CUI [12,3]
C2828389
participation in a clinical trial of any investigational therapy or device within 30 days prior to randomization.
Descrição

Study Subject Participation Status | Therapies, Investigational | Investigational Medical Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
UMLS CUI [3]
C2346570
treatment with nesiritide within 14 days prior to dosing.
Descrição

Nesiritide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0054015
inability to effectively communicate with study personnel.
Descrição

Lacking Able to communicate Study Personnel

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C2985653
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Similar models

Eligibility Congestive Heart Failure NCT00557661

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Age | Heart failure New York Heart Association Classification
Item
male or female ≥18 years of age diagnosed with nyha class iii or iv heart failure in the last six months
boolean
C0001779 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization
Item
female patients must be post-menopausal or surgically sterile
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
Heart failure | Left ventricular ejection fraction | Volume overload Sign or Symptom Quantity
Item
diagnosed heart failure with left ventricular ejection fraction <40% obtained within the prior 6 months with at least one symptoms or signs of volume overload
boolean
C0018801 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0546817 (UMLS CUI [3,1])
C3540840 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential
Item
women who are pregnant, breast-feeding or of child-bearing potential
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Patients Unstable Clinical
Item
clinically unstable patients
boolean
C0030705 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Major surgery
Item
major surgical procedures within 30 days of entry
boolean
C0679637 (UMLS CUI [1])
Temperature febrile Degrees fahrenheit
Item
febrile temp > 100 degrees f)
boolean
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0456628 (UMLS CUI [1,3])
Carotid disease Symptomatic | Carotid Stenosis Critical | Cerebrovascular accident
Item
symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry
boolean
C0741975 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0007282 (UMLS CUI [2,1])
C1511545 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3])
Vasoactive agent Intravenous | Heart Transplantation Scheduled
Item
currently on iv vasoactive support (e.g., heart transplant candidate)
boolean
C0597639 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0018823 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Syncope Unknown
Item
history of unexplained syncope within the past 3 months
boolean
C0039070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Organ Transplantation
Item
history of organ transplantation
boolean
C0029216 (UMLS CUI [1])
Comorbidity | Heart valve stenosis | Aortic valve disorder | Restrictive cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Pericarditis, Constrictive | Primary pulmonary hypertension | Disease Infiltrating | Congenital heart disease uncorrected | Acute Coronary Syndrome | Restrictive heart failure | Condition Study Subject Participation Status Excluded
Item
comorbidities such as clinically significant cardiac valvular stenosis, aortic valvular disease, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, infiltrative disease, uncorrected congenital heart disease, acute coronary syndrome, restrictive heart failure, or any other condition which, in the opinion of the investigator, would prevent a patient's participation in the study.
boolean
C0009488 (UMLS CUI [1])
C0264878 (UMLS CUI [2])
C1260873 (UMLS CUI [3])
C0007196 (UMLS CUI [4])
C0007194 (UMLS CUI [5])
C0031048 (UMLS CUI [6])
C0152171 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C0332448 (UMLS CUI [8,2])
C0152021 (UMLS CUI [9,1])
C4072785 (UMLS CUI [9,2])
C0948089 (UMLS CUI [10])
C1832374 (UMLS CUI [11])
C0348080 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C2828389 (UMLS CUI [12,3])
Study Subject Participation Status | Therapies, Investigational | Investigational Medical Device
Item
participation in a clinical trial of any investigational therapy or device within 30 days prior to randomization.
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Nesiritide
Item
treatment with nesiritide within 14 days prior to dosing.
boolean
C0054015 (UMLS CUI [1])
Lacking Able to communicate Study Personnel
Item
inability to effectively communicate with study personnel.
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C2985653 (UMLS CUI [1,3])
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