ID

20657

Beschrijving

Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00325910

Link

https://clinicaltrials.gov/show/NCT00325910

Trefwoorden

Versies (1)
  1. 08-03-17 08-03-17 -
Geüploaded op

8 maart 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00325910

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00325910

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all subjects with physician-diagnosed symptomatic heart failure (nyha class i, ii, iii, iv) and type 2 diabetes.
Beschrijving

Heart failure Symptomatic New York Heart Association Classification | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0011860
a diagnosis of type 2 diabetes defined as:
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Definition

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1704788
a previous physician diagnosis of type 2 diabetes as documented in the subject's clinical record or;
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Medical Record

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0025102
receiving oral antihyperglycemic agents or;
Beschrijving

Hypoglycemic Agents Oral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C1527415
a new diagnosis of type 2 diabetes during the visit within the heart failure clinic or hospital based on a fasting blood glucose ≥7.0 mmol/l or random blood glucose
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus New diagnosis | Fasting blood glucose measurement | Random blood glucose measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C2585997
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0428567
≥11.1 mmol/l accompanied by acute metabolic decompensation or 2 hour plasma glucose in a 75 gram oral glucose tolerance test ≥11.1 mmol/l.
Beschrijving

Acute metabolic decompensation | Plasma Glucose Measurement | Oral Glucose Tolerance Test

Datatype

boolean

Alias
UMLS CUI [1]
C2673978
UMLS CUI [2]
C0202042
UMLS CUI [3]
C0029161
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects currently receiving greater than 1500 mg of metformin therapy per day
Beschrijving

Metformin U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0456683
subjects who are unwilling to change their antidiabetic regimens;
Beschrijving

Antidiabetics Change Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0558080
subjects receiving insulin therapy;
Beschrijving

Insulin regime

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
serum creatinine ≥ 180 μmol/l;
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
a1c < 7.0 percent;
Beschrijving

Glycosylated hemoglobin A Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
inability to communicate (language barrier);
Beschrijving

Able to communicate | Language Barrier

Datatype

boolean

Alias
UMLS CUI [1]
C2364293
UMLS CUI [2]
C0237167
dementia/mental illness;
Beschrijving

Dementia | Mental disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0004936
age < 18 years;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subjects unwilling to complete self-monitoring of serum blood sugars during the trial period.
Beschrijving

Blood Glucose Self-Monitoring Completion Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0558080
those participating in another heart failure or diabetes clinical trial involving medication;
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Heart failure | Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0011849
severe comorbidities or foreshortened life expectancy;
Beschrijving

Comorbidity Severe | Life Expectancy Shortened

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C1282927
subjects who do not provide written informed consent to participate.
Beschrijving

Informed Consent Missing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705492
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00325910

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Symptomatic New York Heart Association Classification | Diabetes Mellitus, Non-Insulin-Dependent
Item
all subjects with physician-diagnosed symptomatic heart failure (nyha class i, ii, iii, iv) and type 2 diabetes.
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0011860 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus Definition
Item
a diagnosis of type 2 diabetes defined as:
boolean
C0011860 (UMLS CUI [1,1])
C1704788 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Medical Record
Item
a previous physician diagnosis of type 2 diabetes as documented in the subject's clinical record or;
boolean
C0011860 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])
Hypoglycemic Agents Oral
Item
receiving oral antihyperglycemic agents or;
boolean
C0020616 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus New diagnosis | Fasting blood glucose measurement | Random blood glucose measurement
Item
a new diagnosis of type 2 diabetes during the visit within the heart failure clinic or hospital based on a fasting blood glucose ≥7.0 mmol/l or random blood glucose
boolean
C0011860 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
C0428568 (UMLS CUI [2])
C0428567 (UMLS CUI [3])
Acute metabolic decompensation | Plasma Glucose Measurement | Oral Glucose Tolerance Test
Item
≥11.1 mmol/l accompanied by acute metabolic decompensation or 2 hour plasma glucose in a 75 gram oral glucose tolerance test ≥11.1 mmol/l.
boolean
C2673978 (UMLS CUI [1])
C0202042 (UMLS CUI [2])
C0029161 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Metformin U/day
Item
subjects currently receiving greater than 1500 mg of metformin therapy per day
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Antidiabetics Change Unwilling
Item
subjects who are unwilling to change their antidiabetic regimens;
boolean
C0935929 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Insulin regime
Item
subjects receiving insulin therapy;
boolean
C0557978 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≥ 180 μmol/l;
boolean
C0201976 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
a1c < 7.0 percent;
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Able to communicate | Language Barrier
Item
inability to communicate (language barrier);
boolean
C2364293 (UMLS CUI [1])
C0237167 (UMLS CUI [2])
Dementia | Mental disorder
Item
dementia/mental illness;
boolean
C0497327 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Age
Item
age < 18 years;
boolean
C0001779 (UMLS CUI [1])
Blood Glucose Self-Monitoring Completion Unwilling
Item
subjects unwilling to complete self-monitoring of serum blood sugars during the trial period.
boolean
C0005803 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs | Heart failure | Diabetes Mellitus
Item
those participating in another heart failure or diabetes clinical trial involving medication;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
Comorbidity Severe | Life Expectancy Shortened
Item
severe comorbidities or foreshortened life expectancy;
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2,1])
C1282927 (UMLS CUI [2,2])
Informed Consent Missing
Item
subjects who do not provide written informed consent to participate.
boolean
C0021430 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
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