ID

39624

Description

Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01956006

Link

https://clinicaltrials.gov/show/NCT01956006

Keywords

Versions (1)
  1. 2/4/20 2/4/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 4, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01956006

English

Eligibility Heart Failure NCT01956006

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
advanced hf (current inpatients) with no further clinical options as defined by treating cardiologist.
Description

Heart failure Advanced | Inpatient

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0021562
nyha iii-iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
lvef<35%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
recurrent hospitalization (>/=3 admissions in the preceding 12 months) for hf
Description

Hospitalization Due to Heart Failure Repeated | Hospital admission Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C0205341
UMLS CUI [2,1]
C0184666
UMLS CUI [2,2]
C1265611
on optimal tolerated medical/device therapy. stable therapy for 48hrs.
Description

Therapy Optimal | Device therapy Optimal | Therapy Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [2,1]
C1504335
UMLS CUI [2,2]
C2698651
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0205360
age 18-85 yrs
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypotension (bpsys<85)
Description

Hypotension | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
unstable rhythm including frequent non-sustained ventricular tachycardia or poorly controlled atrial fibrillation (ventricular rate >100).
Description

Cardiac Arrhythmia | Ventricular Tachycardia Frequent | Atrial Fibrillation Poorly controlled | Ventricular Heart Rate

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2,1]
C0042514
UMLS CUI [2,2]
C0332183
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C3853134
UMLS CUI [4]
C1883530
severe renal impairment cr>250umol/l or dialysis.
Description

Renal Insufficiency Severe | Creatinine measurement, serum | Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0011946
other life-threatening eg neoplastic, haematological, hepatic or pulmonary disease.
Description

Neoplastic disease Life Threatening | Hematological Disease Life Threatening | Liver disease Life Threatening | Lung disease Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C1882062
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0018939
UMLS CUI [2,2]
C2826244
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C2826244
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C2826244
pregnancy or female with childbearing potential and inability to use contraception
Description

Pregnancy | Childbearing Potential Contraceptive methods Unable

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Heart Failure NCT01956006

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Advanced | Inpatient
Item
advanced hf (current inpatients) with no further clinical options as defined by treating cardiologist.
boolean
C0018801 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0021562 (UMLS CUI [2])
New York Heart Association Classification
Item
nyha iii-iv
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef<35%
boolean
C0428772 (UMLS CUI [1])
Hospitalization Due to Heart Failure Repeated | Hospital admission Quantity
Item
recurrent hospitalization (>/=3 admissions in the preceding 12 months) for hf
boolean
C3898876 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0184666 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Therapy Optimal | Device therapy Optimal | Therapy Stable
Item
on optimal tolerated medical/device therapy. stable therapy for 48hrs.
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C1504335 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Age
Item
age 18-85 yrs
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypotension | Systolic Pressure
Item
hypotension (bpsys<85)
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Cardiac Arrhythmia | Ventricular Tachycardia Frequent | Atrial Fibrillation Poorly controlled | Ventricular Heart Rate
Item
unstable rhythm including frequent non-sustained ventricular tachycardia or poorly controlled atrial fibrillation (ventricular rate >100).
boolean
C0003811 (UMLS CUI [1])
C0042514 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
C0004238 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C1883530 (UMLS CUI [4])
Renal Insufficiency Severe | Creatinine measurement, serum | Dialysis
Item
severe renal impairment cr>250umol/l or dialysis.
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Neoplastic disease Life Threatening | Hematological Disease Life Threatening | Liver disease Life Threatening | Lung disease Life Threatening
Item
other life-threatening eg neoplastic, haematological, hepatic or pulmonary disease.
boolean
C1882062 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0018939 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
C0024115 (UMLS CUI [4,1])
C2826244 (UMLS CUI [4,2])
Pregnancy | Childbearing Potential Contraceptive methods Unable
Item
pregnancy or female with childbearing potential and inability to use contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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