ID

17448

Description

A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00091520

Link

https://clinicaltrials.gov/show/NCT00091520

Keywords

Versions (1)
  1. 9/14/16 9/14/16 -
Uploaded on

September 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00091520

English

Eligibility Heart Failure, Congestive NCT00091520

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
had at least two qualifying hospitalizations or hospitalization equivalents in the past year, with the most recent hospitalization or hospitalization equivalent within the past 60 days, but who has been out of the hospital at least 5 days (the day of discharge is day 0)
Description

Hospitalization Qualifying Quantity | Hospitalization Equivalent Qualifying Quantity | Patient Discharge

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1514624
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0205163
UMLS CUI [2,3]
C1514624
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C0030685
have documentation indicating that the patient was consistently new york heart association (nyha) class iii or iv during the 60 days before randomization
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
have a left ventricular ejection fraction less than 40% (measured within 24 weeks before randomization)
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
are (1)nyha class iv or (2)nyha class iii with highest calculated crcl, 60ml/min within the previous 30 days
Description

New York Heart Association Class IV | New York Heart Association Class III | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C1882087
UMLS CUI [2]
C1882086
UMLS CUI [3]
C0373595
are receiving optimal treatment with long-term oral medications (e.g., diuretics, angiotensin converting enzyme (ace) inhibitors, angiotensin ii receptor blockers (arbs), and beta blockers, unless these are documented to be contraindicated or not tolerated)
Description

oral medication Long-term | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists | Medical contraindication oral medication | intolerance to oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C0443252
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0001645
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0175795
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0175795
agree to come to the clinic up to 2 times per week (according to randomization) for 16 weeks of study drug infusions and to participate in all required follow-up assessments through week 24. in addition, agree to be contacted monthly after week 24 for follow-up, until the entire study has been completed
Description

Protocol Compliance | Investigational New Drugs Infusion | Clinical Study Follow-up

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0574032
UMLS CUI [3]
C3274571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have systolic blood pressure consistently <90mm hg
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
are unable or unwilling to discontinue intermittent or continuous infusions of dopamine, dobutamine, milrinone, nitroglycerin, or open-label natrecor beginning at the time of the screening visit
Description

Infusion Discontinue Unable | Dopamine | Dobutamine | Milrinone | Nitroglycerin | Nesiritide

Data type

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0013030
UMLS CUI [3]
C0012963
UMLS CUI [4]
C0128513
UMLS CUI [5]
C0017887
UMLS CUI [6]
C0054015
have required recent outpatient iv vasoactive (milrinone, dobutamine, dopamine, nitroglycerin, or open-label natrecor) therapy as defined as >2 outpatient (excluding emergency room or inpatient) infusions in the last 30 days without a subsequent hospitalization
Description

Infusion care Vasoactive | Milrinone | Dobutamine | Dopamine | Nitroglycerin | Nesiritide | Outpatient Infusion Therapy Quantity | Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C2958553
UMLS CUI [1,2]
C1980011
UMLS CUI [2]
C0128513
UMLS CUI [3]
C0012963
UMLS CUI [4]
C0013030
UMLS CUI [5]
C0017887
UMLS CUI [6]
C0054015
UMLS CUI [7,1]
C0242944
UMLS CUI [7,2]
C1265611
UMLS CUI [8]
C0019993
had, or during the course of the study are anticipated to have, any organ transplantation (heart, liver, lung, kidney, or bone marrow)
Description

Organ Transplantation | Heart Transplantation | Transplantation of liver | Lung Transplantation | Kidney Transplantation | Bone Marrow Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2]
C0018823
UMLS CUI [3]
C0023911
UMLS CUI [4]
C0024128
UMLS CUI [5]
C0022671
UMLS CUI [6]
C0005961
had a biventricular pacemaker placed within the 45 days before randomization or a single or dual chamber pacemaker or an automatic implantable cardiac defibrillator placed within the 15 days before randomization
Description

Biventricular Pacemaker Implantation | Single Chamber Pacemaker Implantation | Dual Chamber Pacemaker Implantation | Implantation of automatic cardiac defibrillator

Data type

boolean

Alias
UMLS CUI [1,1]
C1719274
UMLS CUI [1,2]
C0021107
UMLS CUI [2,1]
C2911682
UMLS CUI [2,2]
C0021107
UMLS CUI [3,1]
C2911683
UMLS CUI [3,2]
C0021107
UMLS CUI [4]
C0397417
have cardiogenic shock, volume depletion, or any other clinical condition at the time of randomization that would contraindicate the administration of natrecor
Description

medical condition Contraindication Nesiritide | Shock, Cardiogenic | Hypovolemia

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C0054015
UMLS CUI [2]
C0036980
UMLS CUI [3]
C0546884
are currently receiving chronic dialysis or have the expectation that dialysis will be required during the next 12 months.
Description

Dialysis chronic | Dialysis Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C1517001
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Similar models

Eligibility Heart Failure, Congestive NCT00091520

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hospitalization Qualifying Quantity | Hospitalization Equivalent Qualifying Quantity | Patient Discharge
Item
had at least two qualifying hospitalizations or hospitalization equivalents in the past year, with the most recent hospitalization or hospitalization equivalent within the past 60 days, but who has been out of the hospital at least 5 days (the day of discharge is day 0)
boolean
C0019993 (UMLS CUI [1,1])
C1514624 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C1514624 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0030685 (UMLS CUI [3])
New York Heart Association Classification
Item
have documentation indicating that the patient was consistently new york heart association (nyha) class iii or iv during the 60 days before randomization
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
have a left ventricular ejection fraction less than 40% (measured within 24 weeks before randomization)
boolean
C0428772 (UMLS CUI [1])
New York Heart Association Class IV | New York Heart Association Class III | Creatinine clearance measurement
Item
are (1)nyha class iv or (2)nyha class iii with highest calculated crcl, 60ml/min within the previous 30 days
boolean
C1882087 (UMLS CUI [1])
C1882086 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
oral medication Long-term | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists | Medical contraindication oral medication | intolerance to oral medication
Item
are receiving optimal treatment with long-term oral medications (e.g., diuretics, angiotensin converting enzyme (ace) inhibitors, angiotensin ii receptor blockers (arbs), and beta blockers, unless these are documented to be contraindicated or not tolerated)
boolean
C0175795 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0001645 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0175795 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0175795 (UMLS CUI [7,2])
Protocol Compliance | Investigational New Drugs Infusion | Clinical Study Follow-up
Item
agree to come to the clinic up to 2 times per week (according to randomization) for 16 weeks of study drug infusions and to participate in all required follow-up assessments through week 24. in addition, agree to be contacted monthly after week 24 for follow-up, until the entire study has been completed
boolean
C0525058 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C3274571 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure
Item
have systolic blood pressure consistently <90mm hg
boolean
C0871470 (UMLS CUI [1])
Infusion Discontinue Unable | Dopamine | Dobutamine | Milrinone | Nitroglycerin | Nesiritide
Item
are unable or unwilling to discontinue intermittent or continuous infusions of dopamine, dobutamine, milrinone, nitroglycerin, or open-label natrecor beginning at the time of the screening visit
boolean
C0574032 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0013030 (UMLS CUI [2])
C0012963 (UMLS CUI [3])
C0128513 (UMLS CUI [4])
C0017887 (UMLS CUI [5])
C0054015 (UMLS CUI [6])
Infusion care Vasoactive | Milrinone | Dobutamine | Dopamine | Nitroglycerin | Nesiritide | Outpatient Infusion Therapy Quantity | Hospitalization
Item
have required recent outpatient iv vasoactive (milrinone, dobutamine, dopamine, nitroglycerin, or open-label natrecor) therapy as defined as >2 outpatient (excluding emergency room or inpatient) infusions in the last 30 days without a subsequent hospitalization
boolean
C2958553 (UMLS CUI [1,1])
C1980011 (UMLS CUI [1,2])
C0128513 (UMLS CUI [2])
C0012963 (UMLS CUI [3])
C0013030 (UMLS CUI [4])
C0017887 (UMLS CUI [5])
C0054015 (UMLS CUI [6])
C0242944 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0019993 (UMLS CUI [8])
Organ Transplantation | Heart Transplantation | Transplantation of liver | Lung Transplantation | Kidney Transplantation | Bone Marrow Transplantation
Item
had, or during the course of the study are anticipated to have, any organ transplantation (heart, liver, lung, kidney, or bone marrow)
boolean
C0029216 (UMLS CUI [1])
C0018823 (UMLS CUI [2])
C0023911 (UMLS CUI [3])
C0024128 (UMLS CUI [4])
C0022671 (UMLS CUI [5])
C0005961 (UMLS CUI [6])
Biventricular Pacemaker Implantation | Single Chamber Pacemaker Implantation | Dual Chamber Pacemaker Implantation | Implantation of automatic cardiac defibrillator
Item
had a biventricular pacemaker placed within the 45 days before randomization or a single or dual chamber pacemaker or an automatic implantable cardiac defibrillator placed within the 15 days before randomization
boolean
C1719274 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C2911682 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
C2911683 (UMLS CUI [3,1])
C0021107 (UMLS CUI [3,2])
C0397417 (UMLS CUI [4])
medical condition Contraindication Nesiritide | Shock, Cardiogenic | Hypovolemia
Item
have cardiogenic shock, volume depletion, or any other clinical condition at the time of randomization that would contraindicate the administration of natrecor
boolean
C3843040 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0054015 (UMLS CUI [1,3])
C0036980 (UMLS CUI [2])
C0546884 (UMLS CUI [3])
Dialysis chronic | Dialysis Expected
Item
are currently receiving chronic dialysis or have the expectation that dialysis will be required during the next 12 months.
boolean
C0011946 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0011946 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
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