ID

12594

Description

Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF); ODM derived from: https://clinicaltrials.gov/show/NCT00699712

Link

https://clinicaltrials.gov/show/NCT00699712

Keywords

Versions (1)
  1. 12/3/15 12/3/15 -
Uploaded on

December 3, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Decompensated Heart Failure NCT00699712

English

Eligibility Acute Decompensated Heart Failure NCT00699712

1 forms  
Inclusion criteria
Description

Inclusion criteria

hospitalization for ahf
Description

hospitalization for ahf

Data type

boolean

Alias
UMLS CUI [1]
C0019993
in need of hemodynamic monitoring
Description

in need of hemodynamic monitoring

Data type

boolean

Alias
UMLS CUI [1]
C0161959
Exclusion criteria
Description

Exclusion criteria

administration of intravenous radiographic contrast agent within 7 days prior to screening or planned iv contrast media administration in the 4 days after screening or acute contrast-induced nephropathy at the time of screening
Description

administration of intravenous radiographic contrast agent within 7 days prior to screening or planned iv contrast media administration in the 4 days after screening or acute contrast-induced nephropathy at the time of screening

Data type

boolean

Alias
UMLS CUI [1]
C0742799
UMLS CUI [2]
C0268775
current or planned treatment with any iv therapies, including diuretics, vasodilators (including nesiritide), vasopressin antagonists, positive inotropic agents and vasopressors, or mechanical support
Description

current or planned treatment with any iv therapies, including diuretics, vasodilators (including nesiritide), vasopressin antagonists, positive inotropic agents and vasopressors, or mechanical support

Data type

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0348016
current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of screening
Description

current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of screening

Data type

boolean

Alias
UMLS CUI [1]
C0041612
UMLS CUI [2]
C0019014
UMLS CUI [3]
C0011946
significant pulmonary disease
Description

significant pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
known valvular heart disease
Description

valvular heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
any organ transplant recipient or patient currently listed for transplant or admitted for any transplantation.
Description

any organ transplant recipient or patient currently listed for transplant or admitted for any transplantation.

Data type

boolean

Alias
UMLS CUI [1]
C0040732
major surgery within 30 days of screening
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
other major disability or disease with expected survival less than 6 months.
Description

other major disability or disease with expected survival less than 6 months

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0009488
major neurologic event, including cerebrovascular events, in the 60 days prior to screening
Description

major neurologic event, including cerebrovascular events, in the 60 days prior to screening

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0852396
clinical diagnosis of acute coronary syndrome within 45 days of screening
Description

clinical diagnosis of acute coronary syndrome within 45 days of screening

Data type

boolean

Alias
UMLS CUI [1]
C0948089
troponin t ≥ 3 times the upper limit of normal at screening
Description

troponin t ≥ 3 times the upper limit of normal at screening

Data type

boolean

Alias
UMLS CUI [1]
C1141947
significant arrhythmias
Description

significant arrhythmias

Data type

boolean

Alias
UMLS CUI [1]
C0003811
acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy
Description

cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0155686
UMLS CUI [2]
C0878544
liver function abnormality
Description

liver dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days prior to screening
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Acute Decompensated Heart Failure NCT00699712

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
hospitalization for ahf
Item
hospitalization for ahf
boolean
C0019993 (UMLS CUI [1])
in need of hemodynamic monitoring
Item
in need of hemodynamic monitoring
boolean
C0161959 (UMLS CUI [1])
Item Group
Exclusion criteria
administration of intravenous radiographic contrast agent within 7 days prior to screening or planned iv contrast media administration in the 4 days after screening or acute contrast-induced nephropathy at the time of screening
Item
administration of intravenous radiographic contrast agent within 7 days prior to screening or planned iv contrast media administration in the 4 days after screening or acute contrast-induced nephropathy at the time of screening
boolean
C0742799 (UMLS CUI [1])
C0268775 (UMLS CUI [2])
current or planned treatment with any iv therapies, including diuretics, vasodilators (including nesiritide), vasopressin antagonists, positive inotropic agents and vasopressors, or mechanical support
Item
current or planned treatment with any iv therapies, including diuretics, vasodilators (including nesiritide), vasopressin antagonists, positive inotropic agents and vasopressors, or mechanical support
boolean
C2347852 (UMLS CUI [1])
C0348016 (UMLS CUI [2])
current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of screening
Item
current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of screening
boolean
C0041612 (UMLS CUI [1])
C0019014 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
significant pulmonary disease
Item
significant pulmonary disease
boolean
C0024115 (UMLS CUI [1])
valvular heart disease
Item
known valvular heart disease
boolean
C0018824 (UMLS CUI [1])
any organ transplant recipient or patient currently listed for transplant or admitted for any transplantation.
Item
any organ transplant recipient or patient currently listed for transplant or admitted for any transplantation.
boolean
C0040732 (UMLS CUI [1])
major surgery
Item
major surgery within 30 days of screening
boolean
C0679637 (UMLS CUI [1])
other major disability or disease with expected survival less than 6 months
Item
other major disability or disease with expected survival less than 6 months.
boolean
C0023671 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
major neurologic event, including cerebrovascular events, in the 60 days prior to screening
Item
major neurologic event, including cerebrovascular events, in the 60 days prior to screening
boolean
C0027765 (UMLS CUI [1])
C0852396 (UMLS CUI [2])
clinical diagnosis of acute coronary syndrome within 45 days of screening
Item
clinical diagnosis of acute coronary syndrome within 45 days of screening
boolean
C0948089 (UMLS CUI [1])
troponin t ≥ 3 times the upper limit of normal at screening
Item
troponin t ≥ 3 times the upper limit of normal at screening
boolean
C1141947 (UMLS CUI [1])
significant arrhythmias
Item
significant arrhythmias
boolean
C0003811 (UMLS CUI [1])
cardiomyopathy
Item
acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy
boolean
C0155686 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
liver dysfunction
Item
liver function abnormality
boolean
C0086565 (UMLS CUI [1])
study subject participation status
Item
administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days prior to screening
boolean
C2348568 (UMLS CUI [1])
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