ID

12604

Beskrivning

Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01822808

Länk

https://clinicaltrials.gov/show/NCT01822808

Nyckelord

Versioner (1)
  1. 2015-12-04 2015-12-04 -
Uppladdad den

4 december 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Acute Heart Failure NCT01822808

Engelsk

Eligibility Acute Heart Failure NCT01822808

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
> 18 years of age
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
hospital admission for acute heart failure as defined by the presence of acute dyspnea and the presence of clinical signs of heart failure on physical examination.
Beskrivning

hospital admission for acute heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0264714
UMLS CUI [2]
C0019993
where available, nt-probnp >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if bmi > 35 kg/m2, lvef <45 percent assessed by echocardiography or other method within the previous 12 months
Beskrivning

where available, nt-probnp >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if bmi > 35 kg/m2, lvef <45 percent assessed by echocardiography or other method within the previous 12 months

Datatyp

boolean

Alias
UMLS CUI [1]
C3272900
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0428772
background therapy with at least ace-inhibitor or angiotensin receptor blocker (arb) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock)
Beskrivning

background therapy with at least ace-inhibitor or angiotensin receptor blocker (arb) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock)

Datatyp

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
available for regular follow up
Beskrivning

follow up

Datatyp

boolean

Alias
UMLS CUI [1]
C0589120
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently being treated with hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates.
Beskrivning

currently being treated with hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates.

Datatyp

boolean

Alias
UMLS CUI [1]
C0020223
UMLS CUI [2]
C2321306
any intravenous treatment for heart failure, except iv furosemide (eg. iv inotropes, pressors, nitrates or nesiritide) at the time of screening.
Beskrivning

any intravenous treatment for heart failure, except iv furosemide (eg. iv inotropes, pressors, nitrates or nesiritide) at the time of screening

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
systolic blood pressure <100 mmhg
Beskrivning

systolic blood pressure <100 mmhg

Datatyp

boolean

Alias
UMLS CUI [1]
C0020649
plan for revascularization
Beskrivning

plan for revascularization

Datatyp

boolean

Alias
UMLS CUI [1]
C0581603
greater than 96 hours after admission
Beskrivning

greater than 96 hours after admission

Datatyp

boolean

Alias
UMLS CUI [1]
C1320532
reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction, arrhythmia. acute mi is defined as symptoms and major electrocardiogram (ecg) changes(i.e., st segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min.
Beskrivning

reversible etiology of acute heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0027059
UMLS CUI [2]
C0155626
UMLS CUI [3]
C0003811
hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis
Beskrivning

hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0878544
UMLS CUI [2]
C0014117
known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta)
Beskrivning

severe congenital heart disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0152021
severe aortic or mitral stenosis or severe rheumatic mitral regurgitation.
Beskrivning

severe aortic or mitral stenosis or severe rheumatic mitral regurgitation

Datatyp

boolean

Alias
UMLS CUI [1]
C0155572
UMLS CUI [2]
C0155563
renal impairment (defined by creatinine >3 mg/dl) at screening or on any type of dialysis.
Beskrivning

renal impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
known hepatic impairment (total bilirubin >3mg/dl) or increased ammonia levels at screening.
Beskrivning

hepatic impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C0948807
history of systemic lupus erythematous.
Beskrivning

systemic lupus erythematous

Datatyp

boolean

Alias
UMLS CUI [1]
C0024141
stroke or tia within 2 weeks from screening.
Beskrivning

stroke or tia within 2 weeks from screening.

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
women who are pregnant or lactating.
Beskrivning

pregnant or breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
allergy to organic nitrates
Beskrivning

allergy to organic nitrates

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C3654024
history or presence of any other diseases (ie. including malignancies or aids) with a life expectancy of < 12 months
Beskrivning

history or presence of any other diseases (ie. including malignancies or aids) with a life expectancy of < 12 months

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Acute Heart Failure NCT01822808

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
> 18 years of age
boolean
C0001779 (UMLS CUI [1])
hospital admission for acute heart failure
Item
hospital admission for acute heart failure as defined by the presence of acute dyspnea and the presence of clinical signs of heart failure on physical examination.
boolean
C0264714 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
where available, nt-probnp >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if bmi > 35 kg/m2, lvef <45 percent assessed by echocardiography or other method within the previous 12 months
Item
where available, nt-probnp >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if bmi > 35 kg/m2, lvef <45 percent assessed by echocardiography or other method within the previous 12 months
boolean
C3272900 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
background therapy with at least ace-inhibitor or angiotensin receptor blocker (arb) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock)
Item
background therapy with at least ace-inhibitor or angiotensin receptor blocker (arb) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock)
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
follow up
Item
available for regular follow up
boolean
C0589120 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
currently being treated with hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates.
Item
currently being treated with hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates.
boolean
C0020223 (UMLS CUI [1])
C2321306 (UMLS CUI [2])
any intravenous treatment for heart failure, except iv furosemide (eg. iv inotropes, pressors, nitrates or nesiritide) at the time of screening
Item
any intravenous treatment for heart failure, except iv furosemide (eg. iv inotropes, pressors, nitrates or nesiritide) at the time of screening.
boolean
C2347852 (UMLS CUI [1])
systolic blood pressure <100 mmhg
Item
systolic blood pressure <100 mmhg
boolean
C0020649 (UMLS CUI [1])
plan for revascularization
Item
plan for revascularization
boolean
C0581603 (UMLS CUI [1])
greater than 96 hours after admission
Item
greater than 96 hours after admission
boolean
C1320532 (UMLS CUI [1])
reversible etiology of acute heart failure
Item
reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction, arrhythmia. acute mi is defined as symptoms and major electrocardiogram (ecg) changes(i.e., st segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min.
boolean
C0027059 (UMLS CUI [1])
C0155626 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis
Item
hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis
boolean
C0878544 (UMLS CUI [1])
C0014117 (UMLS CUI [2])
severe congenital heart disease
Item
known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta)
boolean
C0152021 (UMLS CUI [1])
severe aortic or mitral stenosis or severe rheumatic mitral regurgitation
Item
severe aortic or mitral stenosis or severe rheumatic mitral regurgitation.
boolean
C0155572 (UMLS CUI [1])
C0155563 (UMLS CUI [2])
renal impairment
Item
renal impairment (defined by creatinine >3 mg/dl) at screening or on any type of dialysis.
boolean
C1565489 (UMLS CUI [1])
hepatic impairment
Item
known hepatic impairment (total bilirubin >3mg/dl) or increased ammonia levels at screening.
boolean
C0948807 (UMLS CUI [1])
systemic lupus erythematous
Item
history of systemic lupus erythematous.
boolean
C0024141 (UMLS CUI [1])
stroke or tia within 2 weeks from screening.
Item
stroke or tia within 2 weeks from screening.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
pregnant or breastfeeding
Item
women who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
allergy to organic nitrates
Item
allergy to organic nitrates
boolean
C0020517 (UMLS CUI [1])
C3654024 (UMLS CUI [2])
history or presence of any other diseases (ie. including malignancies or aids) with a life expectancy of < 12 months
Item
history or presence of any other diseases (ie. including malignancies or aids) with a life expectancy of < 12 months
boolean
C0023671 (UMLS CUI [1])
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