ID

29485

Description

A Trial of Thiamin Supplementation in Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00959075

Link

https://clinicaltrials.gov/show/NCT00959075

Keywords

Versions (2)
  1. 4/3/18 4/3/18 -
  2. 4/3/18 4/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00959075

English

Eligibility Heart Failure NCT00959075

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary diagnosis of ischemic, dilated, idiopathic or valvular heart failure characterized by an ejection fraction of < 45% (echocardiography or radionuclide scan)
Description

Heart failure Ischemic Principal diagnosis | Heart failure Dilated Principal diagnosis | Heart failure idiopathic Principal diagnosis | Heart Valve Failure Principal diagnosis | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Radionuclide Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0475224
UMLS CUI [1,3]
C0332137
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0700124
UMLS CUI [2,3]
C0332137
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0332240
UMLS CUI [3,3]
C0332137
UMLS CUI [4,1]
C0018826
UMLS CUI [4,2]
C0231174
UMLS CUI [4,3]
C0332137
UMLS CUI [5,1]
C0232174
UMLS CUI [5,2]
C0013516
UMLS CUI [6,1]
C0232174
UMLS CUI [6,2]
C0034606
have an optimized medication regimen (ace inhibitor or angiotensin receptor blocker, and beta blocker at target doses, or up-titrated to the maximum doses as tolerated)
Description

Optimization of medication | Angiotensin-Converting Enzyme Inhibitors Target Dose | Angiotensin II receptor antagonist Target Dose | Adrenergic beta-1 Receptor Antagonists Target Dose | Angiotensin-Converting Enzyme Inhibitors Maximum Tolerated Dose | Angiotensin II receptor antagonist Maximum Tolerated Dose | Adrenergic beta-1 Receptor Antagonists Maximum Tolerated Dose

Data type

boolean

Alias
UMLS CUI [1]
C4075704
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0178602
UMLS CUI [3,1]
C0521942
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0178602
UMLS CUI [4,1]
C0304516
UMLS CUI [4,2]
C1521840
UMLS CUI [4,3]
C0178602
UMLS CUI [5,1]
C0003015
UMLS CUI [5,2]
C0752079
UMLS CUI [6,1]
C0521942
UMLS CUI [6,2]
C0752079
UMLS CUI [7,1]
C0304516
UMLS CUI [7,2]
C0752079
been stable (on current medication regimen with no hospitalizations for acute decompensated heart failure > 2 months) prior to entry into the study
Description

Pharmacotherapy Stable | Absence Hospitalization Decompensated cardiac failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0019993
UMLS CUI [2,3]
C0581377
exclusion criteria: participants will be excluded if they are:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
unable or unwilling to provide informed consent
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
have any concurrent condition which would result in thiamin deficiency, namely gastrointestinal disorders, magnesium deficiency, liver disease, thyrotoxicosis, b12 deficiency, folate deficiency, prolonged diarrhoeal disease, dialysis, prolonged fever or infection, recent myocardial infarction, coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery within 3 months), or renal failure
Description

Comorbidity Resulting in Thiamine Deficiency | Gastrointestinal Diseases | Magnesium Deficiency | Liver disease | Thyrotoxicosis | Vitamin B 12 Deficiency | Folic Acid Deficiency | Diarrheal disorder Prolonged | Dialysis | Prolonged fever | Communicable Disease Prolonged | Myocardial Infarction | Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Kidney Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0039841
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0024473
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0040156
UMLS CUI [6]
C0042847
UMLS CUI [7]
C0016412
UMLS CUI [8,1]
C1290807
UMLS CUI [8,2]
C0439590
UMLS CUI [9]
C0011946
UMLS CUI [10]
C0424768
UMLS CUI [11,1]
C0009450
UMLS CUI [11,2]
C0439590
UMLS CUI [12]
C0027051
UMLS CUI [13]
C0877341
UMLS CUI [14]
C1532338
UMLS CUI [15]
C0010055
UMLS CUI [16]
C0035078
are rapidly deteriorating, who are not on a stable medication regimen (2 months or more) or who have been hospitalized for acute decompensated heart failure in the last 2 months
Description

Patient's condition deteriorating Rapidly | Absence Pharmacotherapy Stable | Hospitalization Decompensated cardiac failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0555790
UMLS CUI [1,2]
C0456962
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0581377
are on experimental medications
Description

Experimental drug

Data type

boolean

Alias
UMLS CUI [1]
C0304229
are taking vitamin supplements containing thiamin >10mg/day
Description

Vitamin supplement Containing Thiamine U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0681579
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0039840
UMLS CUI [1,4]
C0456683
consume excessive alcohol (> 3 drinks per day), have a documented history of alcoholism or have documented alcoholic cardiomyopathy
Description

Alcohol intake above recommended sensible limits | Alcoholic Intoxication, Chronic | Cardiomyopathy, Alcoholic

Data type

boolean

Alias
UMLS CUI [1]
C0560219
UMLS CUI [2]
C0001973
UMLS CUI [3]
C0007192
have permanent atrial fibrillation
Description

Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2586056
are pregnant or would like to become pregnant
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
have a right-to-left, bidirectional, or transient right to left cardiac shunts
Description

Right to left cardiac shunt | Bidirectional cardiac shunt | Right to left cardiac shunt Transient

Data type

boolean

Alias
UMLS CUI [1]
C2711956
UMLS CUI [2]
C2711453
UMLS CUI [3,1]
C2711956
UMLS CUI [3,2]
C0205374
have clinically suspected wet beri beri in the opinion of the treating physician
Description

Wet beriberi Clinical Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C0268669
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0750491
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Similar models

Eligibility Heart Failure NCT00959075

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Ischemic Principal diagnosis | Heart failure Dilated Principal diagnosis | Heart failure idiopathic Principal diagnosis | Heart Valve Failure Principal diagnosis | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Radionuclide Imaging
Item
primary diagnosis of ischemic, dilated, idiopathic or valvular heart failure characterized by an ejection fraction of < 45% (echocardiography or radionuclide scan)
boolean
C0018801 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C0332137 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0700124 (UMLS CUI [2,2])
C0332137 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3,1])
C0332240 (UMLS CUI [3,2])
C0332137 (UMLS CUI [3,3])
C0018826 (UMLS CUI [4,1])
C0231174 (UMLS CUI [4,2])
C0332137 (UMLS CUI [4,3])
C0232174 (UMLS CUI [5,1])
C0013516 (UMLS CUI [5,2])
C0232174 (UMLS CUI [6,1])
C0034606 (UMLS CUI [6,2])
Optimization of medication | Angiotensin-Converting Enzyme Inhibitors Target Dose | Angiotensin II receptor antagonist Target Dose | Adrenergic beta-1 Receptor Antagonists Target Dose | Angiotensin-Converting Enzyme Inhibitors Maximum Tolerated Dose | Angiotensin II receptor antagonist Maximum Tolerated Dose | Adrenergic beta-1 Receptor Antagonists Maximum Tolerated Dose
Item
have an optimized medication regimen (ace inhibitor or angiotensin receptor blocker, and beta blocker at target doses, or up-titrated to the maximum doses as tolerated)
boolean
C4075704 (UMLS CUI [1])
C0003015 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0521942 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0304516 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0003015 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
C0521942 (UMLS CUI [6,1])
C0752079 (UMLS CUI [6,2])
C0304516 (UMLS CUI [7,1])
C0752079 (UMLS CUI [7,2])
Pharmacotherapy Stable | Absence Hospitalization Decompensated cardiac failure
Item
been stable (on current medication regimen with no hospitalizations for acute decompensated heart failure > 2 months) prior to entry into the study
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0581377 (UMLS CUI [2,3])
Exclusion Criteria
Item
exclusion criteria: participants will be excluded if they are:
boolean
C0680251 (UMLS CUI [1])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Comorbidity Resulting in Thiamine Deficiency | Gastrointestinal Diseases | Magnesium Deficiency | Liver disease | Thyrotoxicosis | Vitamin B 12 Deficiency | Folic Acid Deficiency | Diarrheal disorder Prolonged | Dialysis | Prolonged fever | Communicable Disease Prolonged | Myocardial Infarction | Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Kidney Failure
Item
have any concurrent condition which would result in thiamin deficiency, namely gastrointestinal disorders, magnesium deficiency, liver disease, thyrotoxicosis, b12 deficiency, folate deficiency, prolonged diarrhoeal disease, dialysis, prolonged fever or infection, recent myocardial infarction, coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery within 3 months), or renal failure
boolean
C0009488 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0039841 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2])
C0024473 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0040156 (UMLS CUI [5])
C0042847 (UMLS CUI [6])
C0016412 (UMLS CUI [7])
C1290807 (UMLS CUI [8,1])
C0439590 (UMLS CUI [8,2])
C0011946 (UMLS CUI [9])
C0424768 (UMLS CUI [10])
C0009450 (UMLS CUI [11,1])
C0439590 (UMLS CUI [11,2])
C0027051 (UMLS CUI [12])
C0877341 (UMLS CUI [13])
C1532338 (UMLS CUI [14])
C0010055 (UMLS CUI [15])
C0035078 (UMLS CUI [16])
Patient's condition deteriorating Rapidly | Absence Pharmacotherapy Stable | Hospitalization Decompensated cardiac failure
Item
are rapidly deteriorating, who are not on a stable medication regimen (2 months or more) or who have been hospitalized for acute decompensated heart failure in the last 2 months
boolean
C0555790 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0019993 (UMLS CUI [3,1])
C0581377 (UMLS CUI [3,2])
Experimental drug
Item
are on experimental medications
boolean
C0304229 (UMLS CUI [1])
Vitamin supplement Containing Thiamine U/day
Item
are taking vitamin supplements containing thiamin >10mg/day
boolean
C0681579 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0039840 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Alcohol intake above recommended sensible limits | Alcoholic Intoxication, Chronic | Cardiomyopathy, Alcoholic
Item
consume excessive alcohol (> 3 drinks per day), have a documented history of alcoholism or have documented alcoholic cardiomyopathy
boolean
C0560219 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C0007192 (UMLS CUI [3])
Permanent atrial fibrillation
Item
have permanent atrial fibrillation
boolean
C2586056 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
are pregnant or would like to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Right to left cardiac shunt | Bidirectional cardiac shunt | Right to left cardiac shunt Transient
Item
have a right-to-left, bidirectional, or transient right to left cardiac shunts
boolean
C2711956 (UMLS CUI [1])
C2711453 (UMLS CUI [2])
C2711956 (UMLS CUI [3,1])
C0205374 (UMLS CUI [3,2])
Wet beriberi Clinical Suspected
Item
have clinically suspected wet beri beri in the opinion of the treating physician
boolean
C0268669 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
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