ID

35910

Beskrivning

Safety and Efficacy of the Combination of Loop With Thiazide-type Diuretics in Patients With Decompensated Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01647932

Länk

https://clinicaltrials.gov/show/NCT01647932

Nyckelord

  1. 2019-04-03 2019-04-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 april 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Heart Failure NCT01647932

Eligibility Heart Failure NCT01647932

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of chronic heart failure
Beskrivning

Chronic heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0264716
admission for acute decompensated heart failure
Beskrivning

Admission Decompensated cardiac failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0581377
there is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction
Beskrivning

Heart failure Etiology Unspecified | Cardiac ejection fraction Unspecified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0205370
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0205370
receipt of an oral loop diuretic for at least 1 month before hospitalization, at a dose between 80 mg and 240 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of torasemide or 1 mg of bumetanide was considered to be equivalent to 40 mg of furosemide)
Beskrivning

Loop Diuretics Oral | Furosemide Dose U/day | Torsemide Dose U/day | Bumetanide Dose U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0354100
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0016860
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0076840
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0456683
UMLS CUI [4,1]
C0006376
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0456683
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
other etiologies of fluid overload different from heart failure
Beskrivning

Fluid overload | Etiology Different Heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0546817
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1705242
UMLS CUI [2,3]
C0018801
hyponatremia: any symptomatic sodium value or a sodium level below 125mmol/l
Beskrivning

Hyponatremia | Sodium Value Symptomatic | Sodium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0020625
UMLS CUI [2,1]
C0037473
UMLS CUI [2,2]
C1522609
UMLS CUI [2,3]
C0231220
UMLS CUI [3]
C0337443
unstable patients: acute coronary syndrome, cardiogenic shock or icu admission.
Beskrivning

Patients Unstable status | Acute Coronary Syndrome | Shock, Cardiogenic | Admission to intensive care unit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0036980
UMLS CUI [4]
C0583239
patients requiring inotropic agents or renal replacement therapies
Beskrivning

Patient need for Inotropic agent | Patient need for Renal Replacement Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0304509
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0206074
life expectancy < 6 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
prior treatment with thiazide-type diuretics
Beskrivning

Thiazide Diuretics

Datatyp

boolean

Alias
UMLS CUI [1]
C0012802
aldosterone antagonists are permitted if the patient had been taking them on a long-term basis (at least 30 days before randomisation)
Beskrivning

Aldosterone Antagonists Long-term allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002007
UMLS CUI [1,2]
C0443252
UMLS CUI [1,3]
C0683607
pregnancy or breastfeeding period
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active alcoholism and/or other substance abuse
Beskrivning

Alcoholic Intoxication, Chronic | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0038586

Similar models

Eligibility Heart Failure NCT01647932

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic heart failure
Item
history of chronic heart failure
boolean
C0264716 (UMLS CUI [1])
Admission Decompensated cardiac failure
Item
admission for acute decompensated heart failure
boolean
C0184666 (UMLS CUI [1,1])
C0581377 (UMLS CUI [1,2])
Heart failure Etiology Unspecified | Cardiac ejection fraction Unspecified
Item
there is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction
boolean
C0018801 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
C0232174 (UMLS CUI [2,1])
C0205370 (UMLS CUI [2,2])
Loop Diuretics Oral | Furosemide Dose U/day | Torsemide Dose U/day | Bumetanide Dose U/day
Item
receipt of an oral loop diuretic for at least 1 month before hospitalization, at a dose between 80 mg and 240 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of torasemide or 1 mg of bumetanide was considered to be equivalent to 40 mg of furosemide)
boolean
C0354100 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0016860 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0076840 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C0006376 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Fluid overload | Etiology Different Heart failure
Item
other etiologies of fluid overload different from heart failure
boolean
C0546817 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
Hyponatremia | Sodium Value Symptomatic | Sodium measurement
Item
hyponatremia: any symptomatic sodium value or a sodium level below 125mmol/l
boolean
C0020625 (UMLS CUI [1])
C0037473 (UMLS CUI [2,1])
C1522609 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C0337443 (UMLS CUI [3])
Patients Unstable status | Acute Coronary Syndrome | Shock, Cardiogenic | Admission to intensive care unit
Item
unstable patients: acute coronary syndrome, cardiogenic shock or icu admission.
boolean
C0030705 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0948089 (UMLS CUI [2])
C0036980 (UMLS CUI [3])
C0583239 (UMLS CUI [4])
Patient need for Inotropic agent | Patient need for Renal Replacement Therapy
Item
patients requiring inotropic agents or renal replacement therapies
boolean
C0686904 (UMLS CUI [1,1])
C0304509 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0206074 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy < 6 months
boolean
C0023671 (UMLS CUI [1])
Thiazide Diuretics
Item
prior treatment with thiazide-type diuretics
boolean
C0012802 (UMLS CUI [1])
Aldosterone Antagonists Long-term allowed
Item
aldosterone antagonists are permitted if the patient had been taking them on a long-term basis (at least 30 days before randomisation)
boolean
C0002007 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Alcoholic Intoxication, Chronic | Substance Use Disorders
Item
active alcoholism and/or other substance abuse
boolean
C0001973 (UMLS CUI [1])
C0038586 (UMLS CUI [2])

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