ID

39624

Beschreibung

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

Stichworte

  1. 04.02.20 04.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Heart Failure NCT01956006

Eligibility Heart Failure NCT01956006

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Heart failure Advanced | Inpatient

Datentyp

boolean

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

New York Heart Association Classification

Datentyp

boolean

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

Left ventricular ejection fraction

Datentyp

boolean

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

Hospitalization Due to Heart Failure Repeated | Hospital admission Quantity

Datentyp

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.
Beschreibung

Therapy Optimal | Device therapy Optimal | Therapy Stable

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

Informed Consent | Protocol Compliance

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypotension (bpsys<85)
Beschreibung

Hypotension | Systolic Pressure

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Renal Insufficiency Severe | Creatinine measurement, serum | Dialysis

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Pregnancy | Childbearing Potential Contraceptive methods Unable

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Heart Failure NCT01956006

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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