ID

17452

Description

Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).; ODM derived from: https://clinicaltrials.gov/show/NCT00159627

Link

https://clinicaltrials.gov/show/NCT00159627

Keywords

Versions (1)
  1. 9/15/16 9/15/16 -
Uploaded on

September 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00159627

English

Eligibility Heart Failure, Congestive NCT00159627

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of chf for greater than 3 months,
Description

Congestive heart failure disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0872146
receiving oral/iv diuretic therapy
Description

Diuretic therapy Oral | Diuretic therapy Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0948575
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0948575
UMLS CUI [2,2]
C1522726
hospitalized for therapy for hf and edema that has not responded to diuretic therapy.
Description

Hospitalization Therapeutic procedure Heart failure | Hospitalization Therapeutic procedure Edema | Diuretic therapy Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0013604
UMLS CUI [3,1]
C0948575
UMLS CUI [3,2]
C0205269
signs and symptoms of ongoing volume overload
Description

Fluid overload Continuous Signs and Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0546817
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0037088
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
myocardial infarction in past 14 days
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
clinical evidence of acute coronary syndrome causing worsening of hf,
Description

Acute Coronary Syndrome Evidence Clinical | Acute Coronary Syndrome Causing Worsening Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0948089
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0948089
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0332271
UMLS CUI [2,4]
C0018801
pregnant or breast-feeding,
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
Description

Valvular disease Primary uncorrected Severe | Pericarditis, Constrictive | Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C4072785
UMLS CUI [1,4]
C0205082
UMLS CUI [2]
C0031048
UMLS CUI [3]
C0007196
UMLS CUI [4]
C0007194
automated implanted cardiac defibrillator (aicd) or synchronization device implanted within the preceding 7 days,
Description

Automatic Implantable Cardioverter-Defibrillator | Cardiac Resynchronization Therapy Device

Data type

boolean

Alias
UMLS CUI [1]
C0972395
UMLS CUI [2]
C2936377
require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
Description

Mechanical ventilation Patient need for | Ultrafiltration Patient need for | Hemodialysis Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0199470
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0041612
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C0019004
UMLS CUI [3,2]
C0686904
deterioration due to an acute or superimposed condition requiring therapy other than diuretics
Description

Deterioration Due to Acute Disease | Therapeutic procedure Patient need for | Diuretics

Data type

boolean

Alias
UMLS CUI [1,1]
C1279889
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0001314
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0686904
UMLS CUI [3]
C0012798
symptomatic ventricular tachycardia,
Description

VENTRICULAR TACHYCARDIA SYMPTOMATIC

Data type

boolean

Alias
UMLS CUI [1]
C0750198
severe concomitant primary hepatic disease,
Description

Liver disease Primary Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205082
severe pulmonary disease,
Description

Lung disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
any other concomitant life-threatening disease,
Description

Comorbidity Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826244
cva in the preceding 6 months,
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
hypotension,
Description

Hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020649
participated in another clinical trial within 30 days,
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
acute contrast nephropathy,
Description

Contrast - Induced Nephropathy

Data type

boolean

Alias
UMLS CUI [1]
C4055183
admitted for heart transplant surgery or have had a heart transplant.
Description

Admission Heart Transplantation | Heart Transplantation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0030673
UMLS CUI [1,2]
C0018823
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C0205156
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Similar models

Eligibility Heart Failure, Congestive NCT00159627

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Congestive heart failure disease length
Item
history of chf for greater than 3 months,
boolean
C0018802 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Diuretic therapy Oral | Diuretic therapy Intravenous
Item
receiving oral/iv diuretic therapy
boolean
C0948575 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0948575 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Hospitalization Therapeutic procedure Heart failure | Hospitalization Therapeutic procedure Edema | Diuretic therapy Unresponsive to Treatment
Item
hospitalized for therapy for hf and edema that has not responded to diuretic therapy.
boolean
C0019993 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0013604 (UMLS CUI [2,3])
C0948575 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
Fluid overload Continuous Signs and Symptoms
Item
signs and symptoms of ongoing volume overload
boolean
C0546817 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction
Item
myocardial infarction in past 14 days
boolean
C0027051 (UMLS CUI [1])
Acute Coronary Syndrome Evidence Clinical | Acute Coronary Syndrome Causing Worsening Heart failure
Item
clinical evidence of acute coronary syndrome causing worsening of hf,
boolean
C0948089 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0948089 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0332271 (UMLS CUI [2,3])
C0018801 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding,
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Valvular disease Primary uncorrected Severe | Pericarditis, Constrictive | Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy
Item
severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
boolean
C3258293 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0031048 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
C0007194 (UMLS CUI [4])
Automatic Implantable Cardioverter-Defibrillator | Cardiac Resynchronization Therapy Device
Item
automated implanted cardiac defibrillator (aicd) or synchronization device implanted within the preceding 7 days,
boolean
C0972395 (UMLS CUI [1])
C2936377 (UMLS CUI [2])
Mechanical ventilation Patient need for | Ultrafiltration Patient need for | Hemodialysis Patient need for
Item
require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
boolean
C0199470 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0041612 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0019004 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Deterioration Due to Acute Disease | Therapeutic procedure Patient need for | Diuretics
Item
deterioration due to an acute or superimposed condition requiring therapy other than diuretics
boolean
C1279889 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0001314 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3])
VENTRICULAR TACHYCARDIA SYMPTOMATIC
Item
symptomatic ventricular tachycardia,
boolean
C0750198 (UMLS CUI [1])
Liver disease Primary Severe
Item
severe concomitant primary hepatic disease,
boolean
C0023895 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Lung disease Severe
Item
severe pulmonary disease,
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Comorbidity Life Threatening
Item
any other concomitant life-threatening disease,
boolean
C0009488 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Cerebrovascular accident
Item
cva in the preceding 6 months,
boolean
C0038454 (UMLS CUI [1])
Hypotension
Item
hypotension,
boolean
C0020649 (UMLS CUI [1])
Study Subject Participation Status
Item
participated in another clinical trial within 30 days,
boolean
C2348568 (UMLS CUI [1])
Contrast - Induced Nephropathy
Item
acute contrast nephropathy,
boolean
C4055183 (UMLS CUI [1])
Admission Heart Transplantation | Heart Transplantation Previous
Item
admitted for heart transplant surgery or have had a heart transplant.
boolean
C0030673 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0018823 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
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