ID

13655

Description

Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01251406

Link

https://clinicaltrials.gov/show/NCT01251406

Keywords

  1. 2/23/16 2/23/16 -
Uploaded on

February 23, 2016

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.

Itemgroup comments for :

Item comments for :


No comments

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

Eligibility Chronic Heart Failure NCT01251406

Eligibility Chronic Heart Failure NCT01251406

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
male or female subjects.
Description

gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
have chronic heart failure defined as nyha classification of ii or iii.
Description

nyha classification; chronic heart failure

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0264716
be on a stable regimen of acei/arb and/or beta-blocker 3 months prior to receiving study medication and are expected to remain on a stable hf medication regime throughout the duration of the trial.
Description

medication regimen beta-blocker

Data type

boolean

Alias
UMLS CUI [1,1]
C0237125
UMLS CUI [1,2]
C0001645
left ventricular ejection fraction (lvef) of < 35% as determined at screening by 2-d echocardiography.
Description

left ventricular ejection fraction; echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0013516
is able to understand and provide informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
if subject has dilated cardiomyopathy, ischemic heart disease or corrected valvular heart disease, and had surgery to repair or replace value, the surgery must have been performed 3 months prior to receiving study medication and the surgical area is functioning normally.
Description

dilated cardiomyopathy; surgery

Data type

boolean

Alias
UMLS CUI [1]
C0007193
UMLS CUI [2]
C0543467
proper birth control must be used at least 3 weeks prior to the study (women only), during the infusion period of study drug (men and women), 4-weeks after study drug administration (men and women) and the remaining 11 months in the study follow-up (women). women must have a negative pregnancy test at screening.
Description

Contraception status; negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0427780
no greater than mild pericardial effusion < 0.5 cm on echocardiography (roughly corresponds to < 100 ml).
Description

pericardial effusion

Data type

boolean

Alias
UMLS CUI [1]
C0031039
have an implantable cardioverter-defibrillator (icd). the icd should have been implanted at least 3 months prior to receiving study medication. patients should undergo interrogation of their icds between 1 and 7 days before randomization to drug for the previous thirty (30) days. this interrogation would include surveillance for ventricular arrhythmias as well as assessment of icd discharge(s) and/or anti-tachycardia pacing.
Description

implantable cardioverter-defibrillator; ventricular arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C0085612
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has chronic heart failure classified as nyha class i or iv.
Description

chronic heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0264716
has a history of any malignancy or positive test as specified in the pre-cancer screening.
Description

medical history malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
have other conditions which in the opinion of the investigator preclude participation in the study, e.g. serious co-morbidity, known or suspected substance abuse or non-compliance.
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
has a body weight >350lbs.
Description

body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
has had any cause hospitalization 30 days prior to screening.
Description

hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993

Similar models

Eligibility Chronic Heart Failure NCT01251406

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
gender
Item
male or female subjects.
boolean
C0079399 (UMLS CUI [1])
nyha classification; chronic heart failure
Item
have chronic heart failure defined as nyha classification of ii or iii.
boolean
C1275491 (UMLS CUI [1])
C0264716 (UMLS CUI [2])
medication regimen beta-blocker
Item
be on a stable regimen of acei/arb and/or beta-blocker 3 months prior to receiving study medication and are expected to remain on a stable hf medication regime throughout the duration of the trial.
boolean
C0237125 (UMLS CUI [1,1])
C0001645 (UMLS CUI [1,2])
left ventricular ejection fraction; echocardiography
Item
left ventricular ejection fraction (lvef) of < 35% as determined at screening by 2-d echocardiography.
boolean
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
informed consent
Item
is able to understand and provide informed consent.
boolean
C0021430 (UMLS CUI [1])
dilated cardiomyopathy; surgery
Item
if subject has dilated cardiomyopathy, ischemic heart disease or corrected valvular heart disease, and had surgery to repair or replace value, the surgery must have been performed 3 months prior to receiving study medication and the surgical area is functioning normally.
boolean
C0007193 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
Contraception status; negative pregnancy test
Item
proper birth control must be used at least 3 weeks prior to the study (women only), during the infusion period of study drug (men and women), 4-weeks after study drug administration (men and women) and the remaining 11 months in the study follow-up (women). women must have a negative pregnancy test at screening.
boolean
C0420837 (UMLS CUI [1])
C0427780 (UMLS CUI [2])
pericardial effusion
Item
no greater than mild pericardial effusion < 0.5 cm on echocardiography (roughly corresponds to < 100 ml).
boolean
C0031039 (UMLS CUI [1])
implantable cardioverter-defibrillator; ventricular arrhythmia
Item
have an implantable cardioverter-defibrillator (icd). the icd should have been implanted at least 3 months prior to receiving study medication. patients should undergo interrogation of their icds between 1 and 7 days before randomization to drug for the previous thirty (30) days. this interrogation would include surveillance for ventricular arrhythmias as well as assessment of icd discharge(s) and/or anti-tachycardia pacing.
boolean
C0162589 (UMLS CUI [1])
C0085612 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
chronic heart failure
Item
has chronic heart failure classified as nyha class i or iv.
boolean
C0264716 (UMLS CUI [1])
medical history malignancy
Item
has a history of any malignancy or positive test as specified in the pre-cancer screening.
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Compliance behavior Limited Comorbidity
Item
have other conditions which in the opinion of the investigator preclude participation in the study, e.g. serious co-morbidity, known or suspected substance abuse or non-compliance.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
body weight
Item
has a body weight >350lbs.
boolean
C0005910 (UMLS CUI [1])
hospitalization
Item
has had any cause hospitalization 30 days prior to screening.
boolean
C0019993 (UMLS CUI [1])

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

Fields marked with * are required.

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