ID

42746

Beskrivning

A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01966601

Länk

https://clinicaltrials.gov/show/NCT01966601

Nyckelord

Versioner (2)
  1. 2015-12-03 2015-12-03 -
  2. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Acute Decompensated Heart Failure NCT01966601

Engelsk

Eligibility Acute Decompensated Heart Failure NCT01966601

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women aged ≥21 years and ≤ 85 years
Beskrivning

women of non-childbearing potential

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
able to provide written informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
pre-existing diagnosis of heart failure
Beskrivning

diagnosis of heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0011900
systolic blood pressure ≥120 mmhg and ≤ 200 mmhg within 30 minutes of randomization
Beskrivning

systolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
ventricular rate ≤125 bpm. patients with rate-controlled persistent or permanent atrial fibrillation (afib) at screening are permitted.
Beskrivning

ventricular rate ≤125 bpm. patients with rate-controlled persistent or permanent atrial fibrillation (afib) at screening are permitted.

Datatyp

boolean

Alias
UMLS CUI [1]
C1883530
UMLS CUI [2]
C0741286
presence of adhf defined by
Beskrivning

presence of adhf

Datatyp

boolean

Alias
UMLS CUI [1]
C1609524
bnp > 400 pg/ml or nt-probnp > 1600 pg/ml
Beskrivning

bnp > 400 pg/ml or nt-probnp > 1600 pg/ml

Datatyp

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
for patients with bmi >30 kg/m2: bnp > 200 pg/ml or nt-probnp > 800 pg/ml
Beskrivning

for patients with bmi >30 kg/m2: bnp > 200 pg/ml or nt-probnp > 800 pg/ml

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C1095989
UMLS CUI [3]
C3272900
for patients with rate-controlled persistent or permanent afib: bnp > 600 pg/ml or nt-probnp > 2400 pg/ml
Beskrivning

for patients with rate-controlled persistent or permanent afib: bnp > 600 pg/ml or nt-probnp > 2400 pg/ml

Datatyp

boolean

Alias
UMLS CUI [1]
C0741286
UMLS CUI [2]
C1095989
UMLS CUI [3]
C3272900
and at least two (2) of the following
Beskrivning

and at least two (2) of the following

Datatyp

boolean

Alias
UMLS CUI [1]
C0011900
congestion on chest radiograph (cxr)
Beskrivning

congestion on chest radiograph

Datatyp

boolean

Alias
UMLS CUI [1]
C3897810
rales by chest auscultation
Beskrivning

rales by chest auscultation

Datatyp

boolean

Alias
UMLS CUI [1]
C0034642
edema ≥ +1 on a 0-3 + scale, indicating indentation of skin with mild digital pressure that requires 10 or more seconds to resolve in any dependent area including extremities or sacral region.
Beskrivning

peripheral edema

Datatyp

boolean

Alias
UMLS CUI [1]
C0085649
elevated jugular venous pressure (≥8 cm h2o)
Beskrivning

elevated jugular venous pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0520861
receipt of a iv loop diuretic at a minimum dose 40 mg furosemide (or equivalent loop diuretic) for the treatment of dyspnea due to adhf at least 1 hour prior to anticipated randomization and the initiation of study medication
Beskrivning

loop diuretic for the treatment of dyspnea due to adhf

Datatyp

boolean

Alias
UMLS CUI [1]
C0354100
UMLS CUI [2]
C1391960
patient report of dyspnea at rest or upon minimal exertion during screening at least one hour after administration of iv loop diuretic
Beskrivning

patient report of dyspnea at rest or upon minimal exertion

Datatyp

boolean

Alias
UMLS CUI [1]
C0013404
UMLS CUI [2]
C0231807
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breast-feeding
Beskrivning

pregnant or breast-feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
acs in the 3 months prior to screening or planned during current admission.
Beskrivning

acs in the 3 months prior to screening

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
temperature >38.5oc
Beskrivning

Fever

Datatyp

boolean

Alias
UMLS CUI [1]
C0015967
clinically significant anemia
Beskrivning

clinically significant anemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
current or planned ultrafiltration, paracentesis, hemofiltration or dialysis at time of screening
Beskrivning

current or planned ultrafiltration, paracentesis, hemofiltration or dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0041612
UMLS CUI [2]
C0019014
UMLS CUI [3]
C0011946
UMLS CUI [4]
C0034115
any mechanical ventilation
Beskrivning

mechanical ventilation

Datatyp

boolean

Alias
UMLS CUI [1]
C0199470
cpap/bipap discontinued less than 1 hour prior to randomization
Beskrivning

cpap/bipap discontinued less than 1 hour prior to randomization

Datatyp

boolean

Alias
UMLS CUI [1]
C0199451
UMLS CUI [2]
C1956423
history of primary pulmonary hypertension
Beskrivning

primary pulmonary hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0152171
history or current use of left ventricular assist devices (lvads) or intra-aortic balloon pumps (iabps)
Beskrivning

history or current use of left ventricular assist devices (lvads) or intra-aortic balloon pumps (iabps)

Datatyp

boolean

Alias
UMLS CUI [1]
C0181598
UMLS CUI [2]
C0702122
intravenous radiographic contrast agent within 72 hours prior to screening or presence of acute contrast induced nephropathy at the time of screening
Beskrivning

intravenous radiographic contrast agent within 72 hours prior to screening or presence of acute contrast induced nephropathy at the time of screening

Datatyp

boolean

Alias
UMLS CUI [1]
C0742799
UMLS CUI [2]
C0268775
presence of clinically significant arrhythmia
Beskrivning

arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0003811
nitroprusside or nesiritide
Beskrivning

nitroprusside or nesiritide

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
intravenous nitrates
Beskrivning

intravenous nitrates

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
use of inotropes
Beskrivning

use of inotropes

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
use of arbs within 7 days of prior to randomization
Beskrivning

use of arbs within 7 days of prior to randomization

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
use of any investigational medication within 30 days
Beskrivning

use of any investigational medication within 30 days

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
clinically significant hypersensitivity or allergy to, or intolerance of, angiotensin receptor blockers
Beskrivning

clinically significant hypersensitivity or allergy to, or intolerance of, angiotensin receptor blockers

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0521942
major surgery within 8 weeks prior to screening
Beskrivning

major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
stroke within 3 months prior to screening
Beskrivning

stroke

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
egfr (smdrd) <20 ml/min/1.73m2 or >75 ml/min/1.73m2 between presentation and randomization
Beskrivning

egfr (smdrd) <20 ml/min/1.73m2 or >75 ml/min/1.73m2 between presentation and randomization

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
post cardiac or renal transplant
Beskrivning

post cardiac or renal transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0040732
listed for renal transplant or cardiac transplant with anticipated transplant time to transplant < 6 months
Beskrivning

listed for transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0040732
history of severe left ventricular outlet obstruction (either valvular or sub-valvular), severe mitral valve stenosis or severe aortic regurgitation
Beskrivning

history of severe left ventricular outlet obstruction (either valvular or sub-valvular), severe mitral valve stenosis or severe aortic regurgitation

Datatyp

boolean

Alias
UMLS CUI [1]
C2919935
UMLS CUI [2]
C0026269
UMLS CUI [3]
C0003504
cardiac valvular abnormality that requires surgical correction
Beskrivning

cardiac valvular abnormality

Datatyp

boolean

Alias
UMLS CUI [1]
C1859330
complex congenital heart disease
Beskrivning

congenital heart disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0152021
hypertrophic or restrictive cardiomyopathy
Beskrivning

hypertrophic or restrictive cardiomyopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0878544
significant pulmonary or hepatic disease that could interfere with the evaluation of safety or efficacy of trv027
Beskrivning

significant pulmonary or hepatic disease that could interfere with the evaluation of safety or efficacy of trv027

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
life expectancy of less than 6 months
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Acute Decompensated Heart Failure NCT01966601

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women aged ≥21 years and ≤ 85 years
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
diagnosis of heart failure
Item
pre-existing diagnosis of heart failure
boolean
C0018801 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
systolic blood pressure
Item
systolic blood pressure ≥120 mmhg and ≤ 200 mmhg within 30 minutes of randomization
boolean
C0871470 (UMLS CUI [1])
ventricular rate ≤125 bpm. patients with rate-controlled persistent or permanent atrial fibrillation (afib) at screening are permitted.
Item
ventricular rate ≤125 bpm. patients with rate-controlled persistent or permanent atrial fibrillation (afib) at screening are permitted.
boolean
C1883530 (UMLS CUI [1])
C0741286 (UMLS CUI [2])
presence of adhf
Item
presence of adhf defined by
boolean
C1609524 (UMLS CUI [1])
bnp > 400 pg/ml or nt-probnp > 1600 pg/ml
Item
bnp > 400 pg/ml or nt-probnp > 1600 pg/ml
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
for patients with bmi >30 kg/m2: bnp > 200 pg/ml or nt-probnp > 800 pg/ml
Item
for patients with bmi >30 kg/m2: bnp > 200 pg/ml or nt-probnp > 800 pg/ml
boolean
C1305855 (UMLS CUI [1])
C1095989 (UMLS CUI [2])
C3272900 (UMLS CUI [3])
for patients with rate-controlled persistent or permanent afib: bnp > 600 pg/ml or nt-probnp > 2400 pg/ml
Item
for patients with rate-controlled persistent or permanent afib: bnp > 600 pg/ml or nt-probnp > 2400 pg/ml
boolean
C0741286 (UMLS CUI [1])
C1095989 (UMLS CUI [2])
C3272900 (UMLS CUI [3])
and at least two (2) of the following
Item
and at least two (2) of the following
boolean
C0011900 (UMLS CUI [1])
congestion on chest radiograph
Item
congestion on chest radiograph (cxr)
boolean
C3897810 (UMLS CUI [1])
rales by chest auscultation
Item
rales by chest auscultation
boolean
C0034642 (UMLS CUI [1])
peripheral edema
Item
edema ≥ +1 on a 0-3 + scale, indicating indentation of skin with mild digital pressure that requires 10 or more seconds to resolve in any dependent area including extremities or sacral region.
boolean
C0085649 (UMLS CUI [1])
elevated jugular venous pressure
Item
elevated jugular venous pressure (≥8 cm h2o)
boolean
C0520861 (UMLS CUI [1])
loop diuretic for the treatment of dyspnea due to adhf
Item
receipt of a iv loop diuretic at a minimum dose 40 mg furosemide (or equivalent loop diuretic) for the treatment of dyspnea due to adhf at least 1 hour prior to anticipated randomization and the initiation of study medication
boolean
C0354100 (UMLS CUI [1])
C1391960 (UMLS CUI [2])
patient report of dyspnea at rest or upon minimal exertion
Item
patient report of dyspnea at rest or upon minimal exertion during screening at least one hour after administration of iv loop diuretic
boolean
C0013404 (UMLS CUI [1])
C0231807 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
pregnant or breast-feeding
Item
women who are pregnant or breast-feeding
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
acs in the 3 months prior to screening
Item
acs in the 3 months prior to screening or planned during current admission.
boolean
C0948089 (UMLS CUI [1])
Fever
Item
temperature >38.5oc
boolean
C0015967 (UMLS CUI [1])
clinically significant anemia
Item
clinically significant anemia
boolean
C0002871 (UMLS CUI [1])
current or planned ultrafiltration, paracentesis, hemofiltration or dialysis
Item
current or planned ultrafiltration, paracentesis, hemofiltration or dialysis at time of screening
boolean
C0041612 (UMLS CUI [1])
C0019014 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
C0034115 (UMLS CUI [4])
mechanical ventilation
Item
any mechanical ventilation
boolean
C0199470 (UMLS CUI [1])
cpap/bipap discontinued less than 1 hour prior to randomization
Item
cpap/bipap discontinued less than 1 hour prior to randomization
boolean
C0199451 (UMLS CUI [1])
C1956423 (UMLS CUI [2])
primary pulmonary hypertension
Item
history of primary pulmonary hypertension
boolean
C0152171 (UMLS CUI [1])
history or current use of left ventricular assist devices (lvads) or intra-aortic balloon pumps (iabps)
Item
history or current use of left ventricular assist devices (lvads) or intra-aortic balloon pumps (iabps)
boolean
C0181598 (UMLS CUI [1])
C0702122 (UMLS CUI [2])
intravenous radiographic contrast agent within 72 hours prior to screening or presence of acute contrast induced nephropathy at the time of screening
Item
intravenous radiographic contrast agent within 72 hours prior to screening or presence of acute contrast induced nephropathy at the time of screening
boolean
C0742799 (UMLS CUI [1])
C0268775 (UMLS CUI [2])
arrhythmia
Item
presence of clinically significant arrhythmia
boolean
C0003811 (UMLS CUI [1])
nitroprusside or nesiritide
Item
nitroprusside or nesiritide
boolean
C2347852 (UMLS CUI [1])
intravenous nitrates
Item
intravenous nitrates
boolean
C2347852 (UMLS CUI [1])
use of inotropes
Item
use of inotropes
boolean
C2347852 (UMLS CUI [1])
use of arbs within 7 days of prior to randomization
Item
use of arbs within 7 days of prior to randomization
boolean
C2347852 (UMLS CUI [1])
use of any investigational medication within 30 days
Item
use of any investigational medication within 30 days
boolean
C2348568 (UMLS CUI [1])
clinically significant hypersensitivity or allergy to, or intolerance of, angiotensin receptor blockers
Item
clinically significant hypersensitivity or allergy to, or intolerance of, angiotensin receptor blockers
boolean
C0020517 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
major surgery
Item
major surgery within 8 weeks prior to screening
boolean
C0679637 (UMLS CUI [1])
stroke
Item
stroke within 3 months prior to screening
boolean
C0038454 (UMLS CUI [1])
egfr (smdrd) <20 ml/min/1.73m2 or >75 ml/min/1.73m2 between presentation and randomization
Item
egfr (smdrd) <20 ml/min/1.73m2 or >75 ml/min/1.73m2 between presentation and randomization
boolean
C3811844 (UMLS CUI [1])
post cardiac or renal transplant
Item
post cardiac or renal transplant
boolean
C0040732 (UMLS CUI [1])
listed for transplant
Item
listed for renal transplant or cardiac transplant with anticipated transplant time to transplant < 6 months
boolean
C0040732 (UMLS CUI [1])
history of severe left ventricular outlet obstruction (either valvular or sub-valvular), severe mitral valve stenosis or severe aortic regurgitation
Item
history of severe left ventricular outlet obstruction (either valvular or sub-valvular), severe mitral valve stenosis or severe aortic regurgitation
boolean
C2919935 (UMLS CUI [1])
C0026269 (UMLS CUI [2])
C0003504 (UMLS CUI [3])
cardiac valvular abnormality
Item
cardiac valvular abnormality that requires surgical correction
boolean
C1859330 (UMLS CUI [1])
congenital heart disease
Item
complex congenital heart disease
boolean
C0152021 (UMLS CUI [1])
hypertrophic or restrictive cardiomyopathy
Item
hypertrophic or restrictive cardiomyopathy
boolean
C0878544 (UMLS CUI [1])
significant pulmonary or hepatic disease that could interfere with the evaluation of safety or efficacy of trv027
Item
significant pulmonary or hepatic disease that could interfere with the evaluation of safety or efficacy of trv027
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
life expectancy
Item
life expectancy of less than 6 months
boolean
C0023671 (UMLS CUI [1])
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