ID

35199

Beskrivning

Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01982292

Länk

https://clinicaltrials.gov/show/NCT01982292

Nyckelord

Versioner (1)
  1. 2019-02-24 2019-02-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 februari 2019

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Heart Failure NCT01982292

Engelsk

Eligibility Chronic Heart Failure NCT01982292

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
body weight of ≤ 160 kg.
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
subjects with compensated chf (nyha class ii - iii) at time of screening with a prior documented history of chronic heart failure.
Beskrivning

Chronic heart failure Compensated New York Heart Association Classification | History Chronic heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0205432
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0264716
nt-probnp >300 pg/ml (according to central measurement) at visit 1.
Beskrivning

NT-proBNP

Datatyp

boolean

Alias
UMLS CUI [1]
C1963813
subjects treated with appropriate and guideline-indicated chf standard of care.
Beskrivning

Standard of Care Chronic heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0264716
ability to comply with all requirements, including ability to receive at least a 48 hour infusion plus follow-up time required for each dosing visit.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current acute decompensated hf
Beskrivning

Decompensated cardiac failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0581377
any major solid organ transplant recipient or planned anticipated organ transplant within 1 year.
Beskrivning

Recipient Solid organ transplant Major | Organ Transplantation Anticipated Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0730400
UMLS CUI [1,3]
C0205164
UMLS CUI [2,1]
C0029216
UMLS CUI [2,2]
C3840775
UMLS CUI [2,3]
C1301732
documented history of untreated ventricular arrhythmia with syncopal episodes, ventricular tachycardia, or ventricular fibrillation without icd (implantable cardioverter defibrillator) with significant hemodynamic consequences within the 3 months prior to screening.
Beskrivning

Ventricular arrhythmia Syncopal Episode | Tachycardia, Ventricular | Ventricular Fibrillation | Implantable defibrillator Absent | Consequences Hemodynamic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0751534
UMLS CUI [2]
C0042514
UMLS CUI [3]
C0042510
UMLS CUI [4,1]
C0162589
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0686907
UMLS CUI [5,2]
C0019010
presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation: including significant left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy, severe aortic stenosis)
Beskrivning

Disease of mitral valve Hemodynamic Significant | Aortic valve disorder Hemodynamic Significant | Exception Mitral Valve Insufficiency Secondary to Left ventricular dilatation | Ventricular Outflow Obstruction, Left | Hypertrophic Cardiomyopathy | Aortic stenosis, severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026265
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C1260873
UMLS CUI [2,2]
C0019010
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0026266
UMLS CUI [3,3]
C0175668
UMLS CUI [3,4]
C0344911
UMLS CUI [4]
C0023213
UMLS CUI [5]
C0007194
UMLS CUI [6]
C3806272
subjects with severe renal impairment defined as pre-randomization egfr < 30 ml/min/1.73m2 calculated using the smdrd equation and/or those receiving current or planned dialysis or ultrafiltration
Beskrivning

Renal Insufficiency Severe | GFR estimation by MDRD | Dialysis | Dialysis Planned | Ultrafiltration | Ultrafiltration Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2170215
UMLS CUI [3]
C0011946
UMLS CUI [4,1]
C0011946
UMLS CUI [4,2]
C1301732
UMLS CUI [5]
C0041612
UMLS CUI [6,1]
C0041612
UMLS CUI [6,2]
C1301732
other protocol defined inclusion/exclusion criteria may apply.
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Chronic Heart Failure NCT01982292

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Body Weight
Item
body weight of ≤ 160 kg.
boolean
C0005910 (UMLS CUI [1])
Chronic heart failure Compensated New York Heart Association Classification | History Chronic heart failure
Item
subjects with compensated chf (nyha class ii - iii) at time of screening with a prior documented history of chronic heart failure.
boolean
C0264716 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0264716 (UMLS CUI [2,2])
NT-proBNP
Item
nt-probnp >300 pg/ml (according to central measurement) at visit 1.
boolean
C1963813 (UMLS CUI [1])
Standard of Care Chronic heart failure
Item
subjects treated with appropriate and guideline-indicated chf standard of care.
boolean
C2936643 (UMLS CUI [1,1])
C0264716 (UMLS CUI [1,2])
Protocol Compliance
Item
ability to comply with all requirements, including ability to receive at least a 48 hour infusion plus follow-up time required for each dosing visit.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated cardiac failure
Item
current acute decompensated hf
boolean
C0581377 (UMLS CUI [1])
Recipient Solid organ transplant Major | Organ Transplantation Anticipated Planned
Item
any major solid organ transplant recipient or planned anticipated organ transplant within 1 year.
boolean
C1709854 (UMLS CUI [1,1])
C0730400 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0029216 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Ventricular arrhythmia Syncopal Episode | Tachycardia, Ventricular | Ventricular Fibrillation | Implantable defibrillator Absent | Consequences Hemodynamic
Item
documented history of untreated ventricular arrhythmia with syncopal episodes, ventricular tachycardia, or ventricular fibrillation without icd (implantable cardioverter defibrillator) with significant hemodynamic consequences within the 3 months prior to screening.
boolean
C0085612 (UMLS CUI [1,1])
C0751534 (UMLS CUI [1,2])
C0042514 (UMLS CUI [2])
C0042510 (UMLS CUI [3])
C0162589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0686907 (UMLS CUI [5,1])
C0019010 (UMLS CUI [5,2])
Disease of mitral valve Hemodynamic Significant | Aortic valve disorder Hemodynamic Significant | Exception Mitral Valve Insufficiency Secondary to Left ventricular dilatation | Ventricular Outflow Obstruction, Left | Hypertrophic Cardiomyopathy | Aortic stenosis, severe
Item
presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation: including significant left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy, severe aortic stenosis)
boolean
C0026265 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C1260873 (UMLS CUI [2,1])
C0019010 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0026266 (UMLS CUI [3,2])
C0175668 (UMLS CUI [3,3])
C0344911 (UMLS CUI [3,4])
C0023213 (UMLS CUI [4])
C0007194 (UMLS CUI [5])
C3806272 (UMLS CUI [6])
Renal Insufficiency Severe | GFR estimation by MDRD | Dialysis | Dialysis Planned | Ultrafiltration | Ultrafiltration Planned
Item
subjects with severe renal impairment defined as pre-randomization egfr < 30 ml/min/1.73m2 calculated using the smdrd equation and/or those receiving current or planned dialysis or ultrafiltration
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
C0011946 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0041612 (UMLS CUI [5])
C0041612 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
Eligibility Criteria Study Protocol
Item
other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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