ID

13655

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01251406

Nyckelord

Versioner (1)
  1. 2016-02-23 2016-02-23 -
Uppladdad den

23 februari 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Heart Failure NCT01251406

Engelsk

Eligibility Chronic Heart Failure NCT01251406

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years.
Beskrivning

age

Datatyp

boolean

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

gender

Datatyp

boolean

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

nyha classification; chronic heart failure

Datatyp

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.
Beskrivning

medication regimen beta-blocker

Datatyp

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.
Beskrivning

left ventricular ejection fraction; echocardiography

Datatyp

boolean

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

informed consent

Datatyp

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.
Beskrivning

dilated cardiomyopathy; surgery

Datatyp

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.
Beskrivning

Contraception status; negative pregnancy test

Datatyp

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).
Beskrivning

pericardial effusion

Datatyp

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.
Beskrivning

implantable cardioverter-defibrillator; ventricular arrhythmia

Datatyp

boolean

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

Exclusion Criteria

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

chronic heart failure

Datatyp

boolean

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

medical history malignancy

Datatyp

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.
Beskrivning

Compliance behavior Limited Comorbidity

Datatyp

boolean

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

body weight

Datatyp

boolean

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

hospitalization

Datatyp

boolean

Alias
UMLS CUI [1]
C0019993
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Similar models

Eligibility Chronic Heart Failure NCT01251406

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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