ID

28376

Description

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

Link

https://clinicaltrials.gov/show/NCT00557661

Keywords

Versions (1)
  1. 1/9/18 1/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 9, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Congestive Heart Failure NCT00557661

English

Eligibility Congestive Heart Failure NCT00557661

1 forms  
Criteria
Description

Criteria

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

Age | Heart failure New York Heart Association Classification

Data type

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
Description

Postmenopausal state | Female Sterilization

Data type

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
Description

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

Data type

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:
Description

Exclusion Criteria Main

Data type

boolean

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

Pregnancy | Breast Feeding | Childbearing Potential

Data type

boolean

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

Patients Unstable Clinical

Data type

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
Description

Major surgery

Data type

boolean

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

Temperature febrile Degrees fahrenheit

Data type

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
Description

Carotid disease Symptomatic | Carotid Stenosis Critical | Cerebrovascular accident

Data type

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)
Description

Vasoactive agent Intravenous | Heart Transplantation Scheduled

Data type

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
Description

Syncope Unknown

Data type

boolean

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

Organ Transplantation

Data type

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.
Description

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

Data type

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.
Description

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

Data type

boolean

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

Nesiritide

Data type

boolean

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

Lacking Able to communicate Study Personnel

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C2985653
Back to the top of the page

Similar models

Eligibility Congestive Heart Failure NCT00557661

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial