ID

35911

Description

A Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-54452840 in Participants With Heart Failure and Anti-beta1-adrenergic Receptor Autoantibodies; ODM derived from: https://clinicaltrials.gov/show/NCT01798745

Link

https://clinicaltrials.gov/show/NCT01798745

Keywords

Versions (1)
  1. 4/3/19 4/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01798745

English

Eligibility Heart Failure NCT01798745

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have documented medical history of symptomatic (ie, showing symptoms) reduced ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) heart failure due to either ischemic etiology (decreased blood supply to heart) or non-ischemic dilated cardiomyopathy (heart is weakened and enlarged) for at least 4 months prior to the screening visit
Description

Reduced ejection fraction Symptomatic | Heart failure Etiology Ischemic | Heart failure Etiology Dilated Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C4022792
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0475224
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0015127
UMLS CUI [3,3]
C0007193
must have heart failure classified by the new york heart association classification system as class i through iiia
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
must have a left ventricular ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) of < = 45%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
must have blood levels of anti-beta1-adrenergic receptor autoantibodies (antibodies that are involved in developing heart failure) that are above the reference range
Description

beta1-adrenergic receptor Autoantibodies Increased

Data type

boolean

Alias
UMLS CUI [1,1]
C1152727
UMLS CUI [1,2]
C0004358
UMLS CUI [1,3]
C0205217
must have been receiving guideline-directed medical therapy for heart failure for at least 4 months prior to screening and, in addition, be receiving stable and individually optimized drug doses for at least 2 months prior to screening.
Description

Therapy Heart failure | Drug dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0018801
UMLS CUI [2,1]
C0678766
UMLS CUI [2,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of, or current active illness that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could interfere with the study assessments
Description

Illness Study Subject Participation Status Unfavorable | Illness compromises Well Being | Illness Interferes with Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C3813622
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0220825
left ventricular end-diastolic diameter index (a measure of the heart's performance) of <= 32 mm/m2
Description

Left ventricle end diastolic Diameter Index

Data type

boolean

Alias
UMLS CUI [1,1]
C0225897
UMLS CUI [1,2]
C0442709
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0918012
n-terminal pro-brain natriuretic peptide level (a biologic molecule that has been shown to predict cardiac events) that is <= 200 pg/ml in participants with normal sinus rhythm or <= 800 pg/ml in participants with atrial fibrillation
Description

N-Terminal ProB-type Natriuretic Peptide Measurement | Normal sinus rhythm | Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C3272900
UMLS CUI [2]
C0232202
UMLS CUI [3]
C0004238
chronic treatment with immunosuppressive drugs (except for <= 5 mg/day prednisone-equivalent dose)
Description

Immunosuppressive Agents chronic | Exception Prednisone Equivalent U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C0205163
UMLS CUI [2,4]
C0456683
known allergies to peptides or proteins, such as albumin.
Description

Hypersensitivity Peptides | Protein allergy | Hypersensitivity Albumin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0030956
UMLS CUI [2]
C1112677
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0001924
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Similar models

Eligibility Heart Failure NCT01798745

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Reduced ejection fraction Symptomatic | Heart failure Etiology Ischemic | Heart failure Etiology Dilated Cardiomyopathy
Item
must have documented medical history of symptomatic (ie, showing symptoms) reduced ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) heart failure due to either ischemic etiology (decreased blood supply to heart) or non-ischemic dilated cardiomyopathy (heart is weakened and enlarged) for at least 4 months prior to the screening visit
boolean
C4022792 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0475224 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0007193 (UMLS CUI [3,3])
Heart failure New York Heart Association Classification
Item
must have heart failure classified by the new york heart association classification system as class i through iiia
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
must have a left ventricular ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) of < = 45%
boolean
C0428772 (UMLS CUI [1])
beta1-adrenergic receptor Autoantibodies Increased
Item
must have blood levels of anti-beta1-adrenergic receptor autoantibodies (antibodies that are involved in developing heart failure) that are above the reference range
boolean
C1152727 (UMLS CUI [1,1])
C0004358 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
Therapy Heart failure | Drug dose Stable
Item
must have been receiving guideline-directed medical therapy for heart failure for at least 4 months prior to screening and, in addition, be receiving stable and individually optimized drug doses for at least 2 months prior to screening.
boolean
C0087111 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0678766 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Illness Study Subject Participation Status Unfavorable | Illness compromises Well Being | Illness Interferes with Evaluation
Item
history of, or current active illness that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could interfere with the study assessments
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C3813622 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0220825 (UMLS CUI [3,3])
Left ventricle end diastolic Diameter Index
Item
left ventricular end-diastolic diameter index (a measure of the heart's performance) of <= 32 mm/m2
boolean
C0225897 (UMLS CUI [1,1])
C0442709 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0918012 (UMLS CUI [1,4])
N-Terminal ProB-type Natriuretic Peptide Measurement | Normal sinus rhythm | Atrial Fibrillation
Item
n-terminal pro-brain natriuretic peptide level (a biologic molecule that has been shown to predict cardiac events) that is <= 200 pg/ml in participants with normal sinus rhythm or <= 800 pg/ml in participants with atrial fibrillation
boolean
C3272900 (UMLS CUI [1])
C0232202 (UMLS CUI [2])
C0004238 (UMLS CUI [3])
Immunosuppressive Agents chronic | Exception Prednisone Equivalent U/day
Item
chronic treatment with immunosuppressive drugs (except for <= 5 mg/day prednisone-equivalent dose)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Hypersensitivity Peptides | Protein allergy | Hypersensitivity Albumin
Item
known allergies to peptides or proteins, such as albumin.
boolean
C0020517 (UMLS CUI [1,1])
C0030956 (UMLS CUI [1,2])
C1112677 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0001924 (UMLS CUI [3,2])
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