ID

35913

Beschrijving

SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02012179

Link

https://clinicaltrials.gov/show/NCT02012179

Trefwoorden

Versies (1)
  1. 03-04-19 03-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02012179

Engels

Eligibility Heart Failure NCT02012179

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients recruited if they are 18+ years or older, with confirmed diagnosis of hf (both reduced and preserved systolic function are eligible), nyha class ii-iii, and willing to sign informed consent.
Beschrijving

Age | Heart failure New York Heart Association Classification | Reduced systolic function | Function Systolic Maintained | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C4025008
UMLS CUI [4,1]
C0031843
UMLS CUI [4,2]
C0039155
UMLS CUI [4,3]
C1314677
UMLS CUI [5]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects will be excluded if:
Beschrijving

Study Subject Excluded Criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0243161
average dietary intake of <1500 mg/ day by a quantitative or semi-quantitative method
Beschrijving

Intake Dietary Average Quantitative | Intake Dietary Average Semi-quantitative

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0012155
UMLS CUI [1,3]
C1510992
UMLS CUI [1,4]
C0392762
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0012155
UMLS CUI [2,3]
C1510992
UMLS CUI [2,4]
C0522525
serum sodium <130mmol/l
Beschrijving

Serum sodium measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0523891
renal failure (glomerular filtration rate <30 ml/min)
Beschrijving

Kidney Failure | Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0017654
hepatic failure
Beschrijving

Liver Failure

Datatype

boolean

Alias
UMLS CUI [1]
C0085605
uncontrolled thyroid disorder
Beschrijving

Thyroid Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0205318
cardiac device (icd or crt) or revascularization procedure (pci or cabg) in previous month or planned in next 3 months
Beschrijving

Cardiac implant device | Implantable defibrillator | CRT Devices | Revascularization | PCI | CABG | Cardiac implant device Planned | Implantable defibrillator Planned | CRT Device Planned | Revascularization Planned | PCI Planned | CABG Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0581396
UMLS CUI [2]
C0162589
UMLS CUI [3]
C2936377
UMLS CUI [4]
C0581603
UMLS CUI [5]
C1532338
UMLS CUI [6]
C0010055
UMLS CUI [7,1]
C0581396
UMLS CUI [7,2]
C1301732
UMLS CUI [8,1]
C0162589
UMLS CUI [8,2]
C1301732
UMLS CUI [9,1]
C2936377
UMLS CUI [9,2]
C1301732
UMLS CUI [10,1]
C0581603
UMLS CUI [10,2]
C1301732
UMLS CUI [11,1]
C1532338
UMLS CUI [11,2]
C1301732
UMLS CUI [12,1]
C0010055
UMLS CUI [12,2]
C1301732
hospitalization due to cardiovascular causes in previous 1 month
Beschrijving

Hospitalization Due to Cause Cardiovascular

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C3887460
uncontrolled atrial fibrillation (resting heart rate >90 bpm)
Beschrijving

ATRIAL FIBRILLATION UNCONTROLLED | Resting heart rate

Datatype

boolean

Alias
UMLS CUI [1]
C0741284
UMLS CUI [2]
C1821417
active malignancy
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
Moderate dementia | Severe dementia
Beschrijving

Moderate dementia | Severe dementia

Datatype

boolean

Alias
UMLS CUI [1]
C3494871
UMLS CUI [2]
C3494652
enrolled in another interventional research study
Beschrijving

Study Subject Participation Status | Interventional Study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
patients will be excluded, if in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.
Beschrijving

Condition Excludes Compliance Dietary | Condition Excludes Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C0012155
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
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Similar models

Eligibility Heart Failure NCT02012179

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Heart failure New York Heart Association Classification | Reduced systolic function | Function Systolic Maintained | Informed Consent
Item
patients recruited if they are 18+ years or older, with confirmed diagnosis of hf (both reduced and preserved systolic function are eligible), nyha class ii-iii, and willing to sign informed consent.
boolean
C0001779 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C4025008 (UMLS CUI [3])
C0031843 (UMLS CUI [4,1])
C0039155 (UMLS CUI [4,2])
C1314677 (UMLS CUI [4,3])
C0021430 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Study Subject Excluded Criteria
Item
subjects will be excluded if:
boolean
C0681850 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Intake Dietary Average Quantitative | Intake Dietary Average Semi-quantitative
Item
average dietary intake of <1500 mg/ day by a quantitative or semi-quantitative method
boolean
C1512806 (UMLS CUI [1,1])
C0012155 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0392762 (UMLS CUI [1,4])
C1512806 (UMLS CUI [2,1])
C0012155 (UMLS CUI [2,2])
C1510992 (UMLS CUI [2,3])
C0522525 (UMLS CUI [2,4])
Serum sodium measurement
Item
serum sodium <130mmol/l
boolean
C0523891 (UMLS CUI [1])
Kidney Failure | Glomerular Filtration Rate
Item
renal failure (glomerular filtration rate <30 ml/min)
boolean
C0035078 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Liver Failure
Item
hepatic failure
boolean
C0085605 (UMLS CUI [1])
Thyroid Disease Uncontrolled
Item
uncontrolled thyroid disorder
boolean
C0040128 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cardiac implant device | Implantable defibrillator | CRT Devices | Revascularization | PCI | CABG | Cardiac implant device Planned | Implantable defibrillator Planned | CRT Device Planned | Revascularization Planned | PCI Planned | CABG Planned
Item
cardiac device (icd or crt) or revascularization procedure (pci or cabg) in previous month or planned in next 3 months
boolean
C0581396 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C2936377 (UMLS CUI [3])
C0581603 (UMLS CUI [4])
C1532338 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0581396 (UMLS CUI [7,1])
C1301732 (UMLS CUI [7,2])
C0162589 (UMLS CUI [8,1])
C1301732 (UMLS CUI [8,2])
C2936377 (UMLS CUI [9,1])
C1301732 (UMLS CUI [9,2])
C0581603 (UMLS CUI [10,1])
C1301732 (UMLS CUI [10,2])
C1532338 (UMLS CUI [11,1])
C1301732 (UMLS CUI [11,2])
C0010055 (UMLS CUI [12,1])
C1301732 (UMLS CUI [12,2])
Hospitalization Due to Cause Cardiovascular
Item
hospitalization due to cardiovascular causes in previous 1 month
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C3887460 (UMLS CUI [1,4])
ATRIAL FIBRILLATION UNCONTROLLED | Resting heart rate
Item
uncontrolled atrial fibrillation (resting heart rate >90 bpm)
boolean
C0741284 (UMLS CUI [1])
C1821417 (UMLS CUI [2])
Malignant Neoplasms
Item
active malignancy
boolean
C0006826 (UMLS CUI [1])
Moderate dementia | Severe dementia
Item
Moderate dementia | Severe dementia
boolean
C3494871 (UMLS CUI [1])
C3494652 (UMLS CUI [2])
Study Subject Participation Status | Interventional Study
Item
enrolled in another interventional research study
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
Condition Excludes Compliance Dietary | Condition Excludes Protocol Compliance
Item
patients will be excluded, if in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0012155 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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