ID

39436

Descripción

Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF); ODM derived from: https://clinicaltrials.gov/show/NCT01300013

Link

https://clinicaltrials.gov/show/NCT01300013

Palabras clave

Versiones (1)
  1. 10/1/20 10/1/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 de enero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01300013

Inglés

Eligibility Heart Failure NCT01300013

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female 18 - 85 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
hospitalized for worsening heart failure, within 24 hours of initiating iv loop diuretic
Descripción

Hospitalization Heart failure Worsening | Initiation Loop Diuretics Intravenous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0332271
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C0354100
UMLS CUI [2,3]
C1522726
dyspnea due to heart failure, at rest or with minimal exertion
Descripción

Dyspnea Due to Heart failure | Resting Dyspnea | Dyspnea on exertion Minimal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0743330
UMLS CUI [3,1]
C0231807
UMLS CUI [3,2]
C0547040
history of left ventricular ejection fraction (lvef) ≤ 40%
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
elevated brain natriuretic peptide (bnp) or n-terminal fragment bnp (nt-probnp)
Descripción

Brain natriuretic peptide increased | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1095988
UMLS CUI [2]
C3846158
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
receiving iv vasopressor (excluding low dopamine), inotropic or mechanical support
Descripción

Vasoconstrictor Agents Intravenous | Exception Dopamine low | Inotropic agent | Mechanical Circulatory Support

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042397
UMLS CUI [1,2]
C1522726
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013030
UMLS CUI [2,3]
C0205251
UMLS CUI [3]
C0304509
UMLS CUI [4]
C3274791
acute coronary syndrome (acs)
Descripción

Acute Coronary Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948089
within 30 days prior to enrollment: cardiac resynchronization therapy (crt) or implantable cardioverter defibrillator (icd) implantation, acs, coronary revascularization, transient ischemic attack (tia) or stroke, sustained ventricular arrhythmia, or major surgery
Descripción

Cardiac Resynchronization Therapy | Implantable defibrillator insertion | Acute Coronary Syndrome | Coronary revascularisation | Transient Ischemic Attack | Cerebrovascular accident | Ventricular arrhythmia Sustained | Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2]
C0877213
UMLS CUI [3]
C0948089
UMLS CUI [4]
C0877341
UMLS CUI [5]
C0007787
UMLS CUI [6]
C0038454
UMLS CUI [7,1]
C0085612
UMLS CUI [7,2]
C0443318
UMLS CUI [8]
C0679637
severe valvular stenosis, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
Descripción

Valvular stenosis Severe | Hypertrophic Cardiomyopathy | Myocarditis | Pericarditis, Constrictive | Congenital heart disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1883524
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0027059
UMLS CUI [4]
C0031048
UMLS CUI [5]
C0152021
estimated glomerular filtration rate (egfr) < 20 ml/min/1.73m2
Descripción

Estimated Glomerular Filtration Rate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3811844
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Similar models

Eligibility Heart Failure NCT01300013

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female 18 - 85 years
boolean
C0001779 (UMLS CUI [1])
Hospitalization Heart failure Worsening | Initiation Loop Diuretics Intravenous
Item
hospitalized for worsening heart failure, within 24 hours of initiating iv loop diuretic
boolean
C0019993 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0332271 (UMLS CUI [1,3])
C1704686 (UMLS CUI [2,1])
C0354100 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
Dyspnea Due to Heart failure | Resting Dyspnea | Dyspnea on exertion Minimal
Item
dyspnea due to heart failure, at rest or with minimal exertion
boolean
C0013404 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0743330 (UMLS CUI [2])
C0231807 (UMLS CUI [3,1])
C0547040 (UMLS CUI [3,2])
Left ventricular ejection fraction
Item
history of left ventricular ejection fraction (lvef) ≤ 40%
boolean
C0428772 (UMLS CUI [1])
Brain natriuretic peptide increased | Other Coding
Item
elevated brain natriuretic peptide (bnp) or n-terminal fragment bnp (nt-probnp)
boolean
C1095988 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Vasoconstrictor Agents Intravenous | Exception Dopamine low | Inotropic agent | Mechanical Circulatory Support
Item
receiving iv vasopressor (excluding low dopamine), inotropic or mechanical support
boolean
C0042397 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013030 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
C0304509 (UMLS CUI [3])
C3274791 (UMLS CUI [4])
Acute Coronary Syndrome
Item
acute coronary syndrome (acs)
boolean
C0948089 (UMLS CUI [1])
Cardiac Resynchronization Therapy | Implantable defibrillator insertion | Acute Coronary Syndrome | Coronary revascularisation | Transient Ischemic Attack | Cerebrovascular accident | Ventricular arrhythmia Sustained | Major surgery
Item
within 30 days prior to enrollment: cardiac resynchronization therapy (crt) or implantable cardioverter defibrillator (icd) implantation, acs, coronary revascularization, transient ischemic attack (tia) or stroke, sustained ventricular arrhythmia, or major surgery
boolean
C1167956 (UMLS CUI [1])
C0877213 (UMLS CUI [2])
C0948089 (UMLS CUI [3])
C0877341 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0085612 (UMLS CUI [7,1])
C0443318 (UMLS CUI [7,2])
C0679637 (UMLS CUI [8])
Valvular stenosis Severe | Hypertrophic Cardiomyopathy | Myocarditis | Pericarditis, Constrictive | Congenital heart disease
Item
severe valvular stenosis, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
boolean
C1883524 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0007194 (UMLS CUI [2])
C0027059 (UMLS CUI [3])
C0031048 (UMLS CUI [4])
C0152021 (UMLS CUI [5])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate (egfr) < 20 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
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