ID

35910

Description

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

Link

https://clinicaltrials.gov/show/NCT01647932

Keywords

Versions (1)
  1. 4/3/19 4/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01647932

English

Eligibility Heart Failure NCT01647932

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of chronic heart failure
Description

Chronic heart failure

Data type

boolean

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

Admission Decompensated cardiac failure

Data type

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
Description

Heart failure Etiology Unspecified | Cardiac ejection fraction Unspecified

Data type

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)
Description

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

Data type

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
Description

Exclusion Criteria

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

Fluid overload | Etiology Different Heart failure

Data type

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
Description

Hyponatremia | Sodium Value Symptomatic | Sodium measurement

Data type

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.
Description

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

Data type

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
Description

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

Data type

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
Description

Life Expectancy

Data type

boolean

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

Thiazide Diuretics

Data type

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)
Description

Aldosterone Antagonists Long-term allowed

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Alcoholic Intoxication, Chronic | Substance Use Disorders

Data type

boolean

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

Eligibility Heart Failure NCT01647932

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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